A Study Comparing the Efficacy, Safety and Tolerability of Fixed Dose Combination (FDC) of FF/UMEC/VI With the FDC of FF/VI and UMEC/VI; Administered Once-daily Via a Dry Powder Inhaler (DPI) in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
September 11, 2018 updated by: GlaxoSmithKline
A Phase III, 52 Week, Randomized, Double-blind, 3-arm Parallel Group Study, Comparing the Efficacy, Safety and Tolerability of the Fixed Dose Triple Combination FF/UMEC/VI With the Fixed Dose Dual Combinations of FF/VI and UMEC/VI, All Administered Once-daily in the Morning Via a Dry Powder Inhaler in Subjects With Chronic Obstructive Pulmonary Disease
The study evaluates the efficacy of fluticasone furoate/umeclidinium bromide/vilanterol (FF/UMEC/VI) to reduce the annual rate of moderate and severe exacerbations compared with dual therapy of FF/VI or UMEC/VI in subjects with COPD.
Published studies which assessed the use of an 'open' triple therapy (use of Inhaled Corticosteroid [ICS]/ Long-acting Muscarinic Receptor Antagonists [LAMA])/ Long Acting Beta-Agonist [LABA] delivered via multiple inhalers) in moderate-severe COPD patients, reported improvements in lung function, Health Related Quality of Life (HRQoL), hospitalization rates and rescue medication use, compared to dual therapy (ICS/LABA) or LAMA alone.
These studies have also shown similar safety profile with dual or monotherapy doses for periods of up to one year.
Given the clinical experience with FF, UMEC and VI, and that the associated risks with these compounds are anticipated from their known pharmacology, the potential benefit of a new therapy option in patients with moderate to severe COPD supports the further development of the closed triple combination (delivered via one inhaler).
In the current study subjects meeting all inclusion/exclusion criteria will complete 2-week run-in period; 52 week treatment period and a 1-week safety follow-up period.
Eligible subjects will be randomized to one of the following double-blind treatment groups FF/UMEC/VI 100 micrograms (mcg)/62.5
mcg/25 mcg once daily (QD), FF/VI 100 mcg/25 mcg QD, or UMEC/VI 62.5 mcg/25 mcg QD
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
10355
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Berazategui, Argentina, 1886
- GSK Investigational Site
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Berazategui, Buenos Aires, Argentina, B1884AAC
- GSK Investigational Site
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Buenos Aires, Argentina, C1424BSF
- GSK Investigational Site
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Buenos Aires, Argentina, C1120AAC
- GSK Investigational Site
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Buenos Aires, Argentina, C1425BEN
- GSK Investigational Site
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Capital Federal, Argentina, C1440BRR
- GSK Investigational Site
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Ciudad Autonoma de Buenis Aires, Argentina, C1015ABR
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Argentina, C1426ABP
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Argentina, C1128AAF
- GSK Investigational Site
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Ciudad Autónoma de Buenos Aires, Argentina, C1121ABE
- GSK Investigational Site
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Cordoba, Argentina, 5000
- GSK Investigational Site
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Coronel Suarez, Argentina, 7540
- GSK Investigational Site
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Mendoza, Argentina, M5500CCG
- GSK Investigational Site
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Mendoza, Argentina, 5500
- GSK Investigational Site
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Monte Grande, Argentina, 1842
- GSK Investigational Site
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Salta, Argentina, A4400ERH
- GSK Investigational Site
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San Miguel de Tucumán, Argentina, 4000
- GSK Investigational Site
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Santa Fe, Argentina, 3000
- GSK Investigational Site
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Santa Rosa, Argentina, 6300
- GSK Investigational Site
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Buenos Aires
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Bahía Blanca, Buenos Aires, Argentina, B8000AAK
- GSK Investigational Site
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Caba, Buenos Aires, Argentina
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1028AAP
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1414AIF
- GSK Investigational Site
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1425AGC
- GSK Investigational Site
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Florida, Buenos Aires, Argentina, 1602
- GSK Investigational Site
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La Plata, Buenos Aires, Argentina, 1900
- GSK Investigational Site
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Mar del Plata, Buenos Aires, Argentina, B7600FZN
- GSK Investigational Site
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Mar del Plata, Buenos Aires, Argentina, 7600
- GSK Investigational Site
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Nueve de Julio, Buenos Aires, Argentina, B6500BWQ
- GSK Investigational Site
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Paraná, Buenos Aires, Argentina, E3100BHK
- GSK Investigational Site
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Vicente Lopez, Buenos Aires, Argentina, B1602DOH
- GSK Investigational Site
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Córdova
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Cordoba, Córdova, Argentina, X5003DCE
- GSK Investigational Site
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Entre Ríos
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Concepcion del Uruguay, Entre Ríos, Argentina, 3260
- GSK Investigational Site
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Mendoza
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San Rafael, Mendoza, Argentina, 5600
- GSK Investigational Site
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Santa Fe
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Rosario, Santa Fe, Argentina, 2000
- GSK Investigational Site
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Rosario, Santa Fe, Argentina, S2002OJN
- GSK Investigational Site
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Tucumán
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San Miguel de Tucuman, Tucumán, Argentina, 4000
- GSK Investigational Site
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Liverpool, Australia, 2107
- GSK Investigational Site
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New South Wales
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Concord, New South Wales, Australia, 2139
- GSK Investigational Site
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Gosford, New South Wales, Australia, 2250
- GSK Investigational Site
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Maroubra, New South Wales, Australia, 2035
- GSK Investigational Site
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Westmead, New South Wales, Australia, 2145
- GSK Investigational Site
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Queensland
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Cairns, Queensland, Australia, 4870
- GSK Investigational Site
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Carina Heights, Queensland, Australia, 4152
- GSK Investigational Site
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South Australia
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Adelaide, South Australia, Australia, 5000
- GSK Investigational Site
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Daw Park, South Australia, Australia, 5041
- GSK Investigational Site
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Victoria
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Clayton, Victoria, Australia, 3168
- GSK Investigational Site
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Footscray, Victoria, Australia, 3011
- GSK Investigational Site
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Frankston, Victoria, Australia, 3199
- GSK Investigational Site
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Geelong, Victoria, Australia, 3220
- GSK Investigational Site
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Hamilton, Victoria, Australia, 3300
- GSK Investigational Site
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Western Australia
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Murdoch, Western Australia, Australia, 6964
- GSK Investigational Site
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Nedlands, Western Australia, Australia, 6009
- GSK Investigational Site
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Feldbach, Austria, 8330
- GSK Investigational Site
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Feldkirch, Austria, 6800
- GSK Investigational Site
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Grieskirchen, Austria, A-4710
- GSK Investigational Site
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Thalheim bei Wels, Austria, 4600
- GSK Investigational Site
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Vienna, Austria, A-1030
- GSK Investigational Site
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Antwerpen, Belgium, 2060
- GSK Investigational Site
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Brugge, Belgium, 8000
- GSK Investigational Site
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Brussels, Belgium, 1200
- GSK Investigational Site
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Erpent, Belgium, 5101
- GSK Investigational Site
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Genk, Belgium, 3600
- GSK Investigational Site
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Gent, Belgium, 9000
- GSK Investigational Site
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Gilly, Belgium, 6060
- GSK Investigational Site
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Hasselt, Belgium, 3500
- GSK Investigational Site
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Liège, Belgium, 4000
- GSK Investigational Site
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Malmedy, Belgium, 4960
- GSK Investigational Site
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Mechelen, Belgium, 2800
- GSK Investigational Site
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Montigny-Le-Tilleul, Belgium, 6110
- GSK Investigational Site
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Oostende, Belgium, 8400
- GSK Investigational Site
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Roeselaere, Belgium, 8800
- GSK Investigational Site
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Turnhout, Belgium, 2300
- GSK Investigational Site
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Rio de Janeiro, Brazil, 21941-913
- GSK Investigational Site
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São Paulo, Brazil, 04266-010
- GSK Investigational Site
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São Paulo, Brazil, 01323903
- GSK Investigational Site
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São Paulo, Brazil, 05403-000
- GSK Investigational Site
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São Paulo, Brazil, 04023900
- GSK Investigational Site
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Pernambuco
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Recife, Pernambuco, Brazil, 50920-900
- GSK Investigational Site
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Rio Grande Do Sul
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610000
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035-074
- GSK Investigational Site
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Porto Alegre, Rio Grande Do Sul, Brazil, 90480-000
- GSK Investigational Site
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Santa Catarina
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Blumenau, Santa Catarina, Brazil, 89030-101
- GSK Investigational Site
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Florianopolis, Santa Catarina, Brazil, 88040-970
- GSK Investigational Site
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Quebec, Canada, G3K 2P8
- GSK Investigational Site
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Quebec, Canada, G1V 4G5
- GSK Investigational Site
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Alberta
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Edmonton, Alberta, Canada, T6G 2G3
- GSK Investigational Site
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Sherwood Park, Alberta, Canada, T8H 0N2
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canada, R2H 2A6
- GSK Investigational Site
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Winnipeg, Manitoba, Canada, R2K 3S8
- GSK Investigational Site
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New Brunswick
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Moncton, New Brunswick, Canada, E1G 2K5
- GSK Investigational Site
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Nova Scotia
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Truro, Nova Scotia, Canada, B2N 1L2
- GSK Investigational Site
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Ontario
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Burlington, Ontario, Canada, L7N 3V2
- GSK Investigational Site
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Cornwall, Ontario, Canada, K6H4M4
- GSK Investigational Site
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Hamilton, Ontario, Canada, L8N 3Z5
- GSK Investigational Site
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Hamilton, Ontario, Canada, L8L 5G8
- GSK Investigational Site
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Sarnia, Ontario, Canada, N7T 4X3
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3E 1H5
- GSK Investigational Site
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Sudbury, Ontario, Canada, P3A 1Y8
- GSK Investigational Site
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Toronto, Ontario, Canada, M9W 4L6
- GSK Investigational Site
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Toronto, Ontario, Canada, M4S 1Y2
- GSK Investigational Site
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Toronto, Ontario, Canada, M5T 3A9
- GSK Investigational Site
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Toronto, Ontario, Canada, M3J 2C5
- GSK Investigational Site
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Toronto, Ontario, Canada, M9C 4Z5
- GSK Investigational Site
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Windsor, Ontario, Canada, N8X 5A6
- GSK Investigational Site
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Quebec
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Gatineau, Quebec, Canada, J8Y 6S8
- GSK Investigational Site
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Mirabel, Quebec, Canada, J7J 2K8
- GSK Investigational Site
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Montréal, Quebec, Canada, H1M 1B1
- GSK Investigational Site
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St-Charles-Borromée, Quebec, Canada, J6E 2B4
- GSK Investigational Site
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Trois Rivieres, Quebec, Canada, G8T 7A1
- GSK Investigational Site
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Santiago, Chile, 8380453
- GSK Investigational Site
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Santiago, Chile, 7500698
- GSK Investigational Site
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Talcahuano, Chile, 4270918
- GSK Investigational Site
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Viña del Mar, Chile, 2520594
- GSK Investigational Site
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Región Del Biobio
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Concepción, Región Del Biobio, Chile, 4070038
- GSK Investigational Site
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Región Del Maule
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Curicó, Región Del Maule, Chile, 3341643
- GSK Investigational Site
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Talca, Región Del Maule, Chile, 3465584
- GSK Investigational Site
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Región Metro De Santiago
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Puente Alto - Santiago, Región Metro De Santiago, Chile, 8207257
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7510186
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7500692
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7500710
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7750495
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 7860406
- GSK Investigational Site
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Santiago, Región Metro De Santiago, Chile, 8360160
- GSK Investigational Site
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Valparaíso
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Valparaiso, Valparaíso, Chile, 2341131
- GSK Investigational Site
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Viña del Mar, Valparaíso, Chile, 2520024
- GSK Investigational Site
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Beijing, China, 100034
- GSK Investigational Site
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Beijing, China, 100029
- GSK Investigational Site
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Beijing, China, 100050
- GSK Investigational Site
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Beijing, China, 100191
- GSK Investigational Site
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Beijing, China, 100020
- GSK Investigational Site
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Changsha, China, 410013
- GSK Investigational Site
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Chongqing, China, 400038
- GSK Investigational Site
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Chongqing, China, 400037
- GSK Investigational Site
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Chongqing, China
- GSK Investigational Site
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Fuzhou, China, 350025
- GSK Investigational Site
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Guangzhou, China, 510080
- GSK Investigational Site
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Nanchang, China, 330006
- GSK Investigational Site
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Shanghai, China, 200025
- GSK Investigational Site
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Shanghai, China, 200433
- GSK Investigational Site
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Tianjin, China, 300052
- GSK Investigational Site
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Wuxi, China, 214023
- GSK Investigational Site
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Guangdong
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Guangzhou, Guangdong, China, 510080
- GSK Investigational Site
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Guangzhou, Guangdong, China, 510120
- GSK Investigational Site
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Guangzhou, Guangdong, China, 510180
- GSK Investigational Site
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Guangzhou, Guangdong, China, 510630
- GSK Investigational Site
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Guangzhou, Guangdong, China, 510150
- GSK Investigational Site
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Zhanjiang, Guangdong, China, 524001
- GSK Investigational Site
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Guangxi
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Nanning, Guangxi, China, 530021
- GSK Investigational Site
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Hainan
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Haikou, Hainan, China, 570311
- GSK Investigational Site
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Hebei
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Shijiazhuang, Hebei, China, 050000
- GSK Investigational Site
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Jiangsu
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Nanjing, Jiangsu, China, 210029
- GSK Investigational Site
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Nanjing, Jiangsu, China, 210008
- GSK Investigational Site
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Nanjing, Jiangsu, China, 210006
- GSK Investigational Site
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Jiangxi
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Nanchang, Jiangxi, China, 330006
- GSK Investigational Site
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Jilin
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Changchun, Jilin, China, 130041
- GSK Investigational Site
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Liaoning
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Shenyang, Liaoning, China, 110004
- GSK Investigational Site
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Shenyang, Liaoning, China, 110015
- GSK Investigational Site
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Ningxia
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Yinchuan, Ningxia, China, 750004
- GSK Investigational Site
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Shandong
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Jinan, Shandong, China, 250013
- GSK Investigational Site
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Jinan, Shandong, China, 250012
- GSK Investigational Site
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Qingdao, Shandong, China, 266071
- GSK Investigational Site
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Shanxi
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Taiyuan, Shanxi, China, 030001
- GSK Investigational Site
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Xian, Shanxi, China, 710032
- GSK Investigational Site
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Sichuan
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Chengdu, Sichuan, China, 610041
- GSK Investigational Site
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Zhejiang
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Hangzhou, Zhejiang, China
- GSK Investigational Site
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Barranquilla, Colombia
- GSK Investigational Site
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Bogota, Colombia
- GSK Investigational Site
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Bogotá, Colombia
- GSK Investigational Site
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Bogotá, Colombia, 80CO
- GSK Investigational Site
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Medellin, Colombia
- GSK Investigational Site
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Benesov, Czechia, 256 30
- GSK Investigational Site
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Brandys nad Labem, Czechia, 250 01
- GSK Investigational Site
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Cvikov, Czechia, 471 54
- GSK Investigational Site
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Holesov, Czechia, 769 01
- GSK Investigational Site
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Hradec Kralove, Czechia, 500 05
- GSK Investigational Site
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Jaromer, Czechia, 551 01
- GSK Investigational Site
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Olomouc, Czechia, 775 20
- GSK Investigational Site
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Olomouc, Czechia, 772 00
- GSK Investigational Site
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Ostrava - Poruba, Czechia, 70868
- GSK Investigational Site
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Plzen, Czechia, 301 00
- GSK Investigational Site
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Praha 5, Czechia, 150 06
- GSK Investigational Site
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Praha 8, Czechia, 182 00
- GSK Investigational Site
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Tabor, Czechia, 390 19
- GSK Investigational Site
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Teplice, Czechia, 415 10
- GSK Investigational Site
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Trebic, Czechia, 674 01
- GSK Investigational Site
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Aalborg, Denmark, 9100
- GSK Investigational Site
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Aarhus C, Denmark, 8000
- GSK Investigational Site
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Hellerup, Denmark, 2900
- GSK Investigational Site
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Hvidovre, Denmark, 2650
- GSK Investigational Site
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Kolding, Denmark, DK-6000
- GSK Investigational Site
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Odense C, Denmark, 5000
- GSK Investigational Site
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Roskilde, Denmark, 4000
- GSK Investigational Site
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Sønderborg, Denmark, 6400
- GSK Investigational Site
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Espoo, Finland, 02740
- GSK Investigational Site
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Helsinki, Finland, 00290
- GSK Investigational Site
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Jyvaskyla, Finland, 40100
- GSK Investigational Site
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Lohja, Finland, 08200
- GSK Investigational Site
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Tampere, Finland, 33520
- GSK Investigational Site
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Turku, Finland, 20520
- GSK Investigational Site
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Turku, Finland, 20100
- GSK Investigational Site
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Bayonne cedex, France, 64109
- GSK Investigational Site
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Brest Cedex, France, 29609
- GSK Investigational Site
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Briis-sous-Forge, France, 91640
- GSK Investigational Site
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Grenoble cedex 9, France, 38043
- GSK Investigational Site
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Le Mans, France, 72000
- GSK Investigational Site
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Lyon cedex 04, France, 69317
- GSK Investigational Site
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Marseille cedex 03, France, 13331
- GSK Investigational Site
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Montauban cedex, France, 82017
- GSK Investigational Site
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Montpellier cedex 5, France, 34295
- GSK Investigational Site
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Nimes, France, 30900
- GSK Investigational Site
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Orléans cedex 2, France, 45067
- GSK Investigational Site
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Paris, France, 75014
- GSK Investigational Site
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Perpignan, France, 66000
- GSK Investigational Site
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Pessac cedex, France, 33604
- GSK Investigational Site
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Pringy cedex, France, 74374
- GSK Investigational Site
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Rennes Cedex 9, France, 35033
- GSK Investigational Site
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Strasbourg cedex, France, 67091
- GSK Investigational Site
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Toulon, France, 83000
- GSK Investigational Site
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Vandoeuvre-les-Nancy, France, 54511
- GSK Investigational Site
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Berlin, Germany, 10367
- GSK Investigational Site
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Berlin, Germany, 14059
- GSK Investigational Site
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Berlin, Germany, 13086
- GSK Investigational Site
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Berlin, Germany, 13353
- GSK Investigational Site
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Berlin, Germany, 10717
- GSK Investigational Site
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Berlin, Germany, 13187
- GSK Investigational Site
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Berlin, Germany, 10119
- GSK Investigational Site
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Berlin, Germany, 12627
- GSK Investigational Site
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Berlin, Germany, 10969
- GSK Investigational Site
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Berlin, Germany, 12203
- GSK Investigational Site
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Berlin, Germany, 10625
- GSK Investigational Site
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Berlin, Germany, 10961
- GSK Investigational Site
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Berlin, Germany, 13581
- GSK Investigational Site
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Berlin, Germany, 13507
- GSK Investigational Site
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Berlin, Germany, 12157
- GSK Investigational Site
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Berlin, Germany, 12159
- GSK Investigational Site
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Berlin, Germany, 13156
- GSK Investigational Site
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Berlin, Germany, 10247
- GSK Investigational Site
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Berlin, Germany, 12043
- GSK Investigational Site
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Berlin, Germany, 13057
- GSK Investigational Site
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Deggendorf, Germany, 94469
- GSK Investigational Site
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Hamburg, Germany, 22291
- GSK Investigational Site
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Hamburg, Germany, 22299
- GSK Investigational Site
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Hamburg, Germany, 22763
- GSK Investigational Site
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Witten, Germany, 58452
- GSK Investigational Site
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Baden-Wuerttemberg
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Deggingen, Baden-Wuerttemberg, Germany, 73326
- GSK Investigational Site
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Leonberg, Baden-Wuerttemberg, Germany, 71229
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Germany, 68161
- GSK Investigational Site
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Mannheim, Baden-Wuerttemberg, Germany, 68167
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Germany, 70372
- GSK Investigational Site
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Stuttgart, Baden-Wuerttemberg, Germany, 70378
- GSK Investigational Site
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Wiesloch, Baden-Wuerttemberg, Germany, 69168
- GSK Investigational Site
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Bayern
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Aschaffenburg, Bayern, Germany, 63739
- GSK Investigational Site
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Augsburg, Bayern, Germany, 86150
- GSK Investigational Site
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Bad Woerrishofen, Bayern, Germany, 86825
- GSK Investigational Site
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Bamberg, Bayern, Germany, 96049
- GSK Investigational Site
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Dachau, Bayern, Germany, 85221
- GSK Investigational Site
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Dillingen, Bayern, Germany, 89407
- GSK Investigational Site
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Donaustauf, Bayern, Germany, 93093
- GSK Investigational Site
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Garmisch-Partenirchen, Bayern, Germany, 82467
- GSK Investigational Site
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Gauting, Bayern, Germany, 82131
- GSK Investigational Site
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Landsberg, Bayern, Germany, 86899
- GSK Investigational Site
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Muenchen, Bayern, Germany, 80339
- GSK Investigational Site
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Muenchen, Bayern, Germany, 80539
- GSK Investigational Site
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Neu-Ulm, Bayern, Germany, 89231
- GSK Investigational Site
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Nuernberg, Bayern, Germany, 90402
- GSK Investigational Site
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Rosenheim, Bayern, Germany, 83022
- GSK Investigational Site
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Wallerfing, Bayern, Germany, 94574
- GSK Investigational Site
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Brandenburg
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Cottbus, Brandenburg, Germany, 03050
- GSK Investigational Site
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Potsdam, Brandenburg, Germany, 14469
- GSK Investigational Site
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Potsdam, Brandenburg, Germany, 14467
- GSK Investigational Site
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Rathenow, Brandenburg, Germany, 14712
- GSK Investigational Site
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Ruedersdorf, Brandenburg, Germany, 15562
- GSK Investigational Site
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Hessen
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Bensheim, Hessen, Germany, 64625
- GSK Investigational Site
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Frankenberg, Hessen, Germany, 35066
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60596
- GSK Investigational Site
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Frankfurt, Hessen, Germany, 60389
- GSK Investigational Site
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Fulda, Hessen, Germany, 36039
- GSK Investigational Site
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Fuldatal, Hessen, Germany, 34233
- GSK Investigational Site
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Kassel, Hessen, Germany, 34121
- GSK Investigational Site
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Marburg, Hessen, Germany, 35037
- GSK Investigational Site
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Neu isenburg, Hessen, Germany, 63263
- GSK Investigational Site
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Offenbach, Hessen, Germany, 63071
- GSK Investigational Site
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Rodgau, Hessen, Germany, 63110
- GSK Investigational Site
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Ruesselsheim, Hessen, Germany, 65428
- GSK Investigational Site
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Niedersachsen
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Hannover, Niedersachsen, Germany, 30173
- GSK Investigational Site
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Hannover, Niedersachsen, Germany, 30167
- GSK Investigational Site
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Peine, Niedersachsen, Germany, 31224
- GSK Investigational Site
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Wardenburg, Niedersachsen, Germany, 26203
- GSK Investigational Site
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Nordrhein-Westfalen
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Bad Lippspringe, Nordrhein-Westfalen, Germany, 33175
- GSK Investigational Site
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Bergisch Gladbach, Nordrhein-Westfalen, Germany, 51429
- GSK Investigational Site
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Bonn, Nordrhein-Westfalen, Germany, 53119
- GSK Investigational Site
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Bonn, Nordrhein-Westfalen, Germany, 53123
- GSK Investigational Site
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Dortmund, Nordrhein-Westfalen, Germany, 44263
- GSK Investigational Site
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Dueren, Nordrhein-Westfalen, Germany, 52349
- GSK Investigational Site
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Duisburg, Nordrhein-Westfalen, Germany, 47057
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45355
- GSK Investigational Site
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Essen, Nordrhein-Westfalen, Germany, 45277
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Freudenberg, Nordrhein-Westfalen, Germany, 57258
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Gelsenkirchen, Nordrhein-Westfalen, Germany, 45879
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Gummersbach, Nordrhein-Westfalen, Germany, 51643
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Hagen, Nordrhein-Westfalen, Germany, 58089
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Kleve, Nordrhein-Westfalen, Germany, 47533
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Koeln, Nordrhein-Westfalen, Germany, 51065
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Neuss, Nordrhein-Westfalen, Germany, 41462
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Ratingen, Nordrhein-Westfalen, Germany, 40878
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Rheine, Nordrhein-Westfalen, Germany, 48431
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Solingen, Nordrhein-Westfalen, Germany, 42699
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Warendorf, Nordrhein-Westfalen, Germany, 48231
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Witten, Nordrhein-Westfalen, Germany, 58452
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Rheinland-Pfalz
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Bernkastel-Kues, Rheinland-Pfalz, Germany, 54470
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Koblenz, Rheinland-Pfalz, Germany, 56068
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Mainz, Rheinland-Pfalz, Germany, 55116
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Neuwied, Rheinland-Pfalz, Germany, 56564
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Wissen, Rheinland-Pfalz, Germany, 57537
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Saarland
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Saarbruecken, Saarland, Germany, 66111
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Sachsen
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Auerbach, Sachsen, Germany, 08209
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Delitzsch, Sachsen, Germany, 04509
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Leipzg, Sachsen, Germany, 04109
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Leipzig, Sachsen, Germany, 04275
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Leipzig, Sachsen, Germany, 04357
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Leipzig, Sachsen, Germany, 04103
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Leipzig, Sachsen, Germany, 04157
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Sachsen-Anhalt
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Halberstadt, Sachsen-Anhalt, Germany, 38820
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Halle, Sachsen-Anhalt, Germany, 06108
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Hettstedt, Sachsen-Anhalt, Germany, 06333
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Teuchern, Sachsen-Anhalt, Germany, 06682
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Zerbst, Sachsen-Anhalt, Germany, 39261
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Schleswig-Holstein
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Geesthacht, Schleswig-Holstein, Germany, 21502
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Luebeck, Schleswig-Holstein, Germany, 23558
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Reinfeld, Schleswig-Holstein, Germany, 23858
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Schleswig, Schleswig-Holstein, Germany, 24837
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Thueringen
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Gera, Thueringen, Germany, 07548
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Saalfeld, Thueringen, Germany, 07318
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Schmoelln, Thueringen, Germany, 04626
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Kwun Tong, Hong Kong
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Lai Chi Kok, Hong Kong
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Pokfulam, Hong Kong
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Shatin, Hong Kong
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Tuen Mun, Hong Kong
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Afula, Israel, 18101
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Ashkelon, Israel, 78278
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Haifa, Israel, 34362
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Holon, Israel, 58100
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Jerusalem, Israel, 91031
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Jerusalem, Israel, 91120
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Kfar-Saba, Israel, 44281
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Petah Tikva, Israel, 49100
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Ramat Gan, Israel, 52621
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Rehovot, Israel, 76100
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Tel Aviv, Israel, 67891
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Tel-Aviv, Israel, 64239
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Zrifin, Israel, 70300
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Aichi, Japan, 455-8530
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Aichi, Japan, 457-8511
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Aichi, Japan, 471-8513
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Aichi, Japan, 460-0001
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Aichi, Japan, 489-8642
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Aichi, Japan, 457-8510
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Aichi, Japan, 485-0041
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Chiba, Japan, 296-8602
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Chiba, Japan, 278-0004
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Ehime, Japan, 791-0281
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Fukuoka, Japan, 802-0052
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Fukuoka, Japan, 811-1394
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Fukuoka, Japan, 820-8505
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Fukuoka, Japan, 816-0813
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Fukuoka, Japan, 832-0059
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Fukuoka, Japan, 802-0083
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Gifu, Japan, 500-8717
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Gifu, Japan, 509-6134
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Gifu, Japan, 506-8550
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Gunma, Japan, 372-0831
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Gunma, Japan, 373-0807
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Hiroshima, Japan, 722-8503
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Hiroshima, Japan, 734-8530
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Hiroshima, Japan, 735-8585
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Hokkaido, Japan, 060-0033
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Hokkaido, Japan, 001-0901
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Hokkaido, Japan, 064-0915
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Hokkaido, Japan, 070-8644
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Hokkaido, Japan, 063-0005
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Hokkaido, Japan, 080-0805
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Hokkaido, Japan, 053-8506
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Hokkaido, Japan, 062-8618
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Hokkaido, Japan, 064-0801
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Hokkaido, Japan, 071-8132
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Hokkaido, Japan, 078-8211
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Hyogo, Japan, 650-0047
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Hyogo, Japan, 670-0849
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Hyogo, Japan, 653-0013
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Hyogo, Japan, 674-0063
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Hyogo, Japan, 675-8611
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Hyogo, Japan, 672-8064
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Hyogo, Japan, 651-0072
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Hyogo, Japan, 664-8540
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Ibaraki, Japan, 319-1113
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Ibaraki, Japan, 310-0015
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Ibaraki, Japan, 311-3193
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Ibaraki, Japan, 302-0022
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Ibaraki, Japan, 317-0077
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Ishikawa, Japan, 920-8610
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Ishikawa, Japan, 920-8530
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Ishikawa, Japan, 923-8560
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Ishikawa, Japan, 921-8105
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Iwate, Japan, 020-0055
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Kagawa, Japan, 760-0018
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Kagawa, Japan, 760-8538
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Kagawa, Japan, 761-8073
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Kagawa, Japan, 762-8550
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Kanagawa, Japan, 239-0821
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Kanagawa, Japan, 210-0852
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Kanagawa, Japan, 232-0024
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Kanagawa, Japan, 232-0066
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Kanagawa, Japan, 252-5188
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Kanagawa, Japan, 254-8502
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Kochi, Japan, 780-8077
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Kumamoto, Japan, 861-1196
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Kyoto, Japan, 601-1495
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Kyoto, Japan, 615-8087
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Kyoto, Japan, 607-8062
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Mie, Japan, 510-8567
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Mie, Japan, 515-8544
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Miyagi, Japan, 984-8560
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Miyagi, Japan, 985-8506
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Miyagi, Japan, 986-8522
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Miyagi, Japan, 989-1253
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Nagano, Japan, 392-8510
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Niigata, Japan, 940-0856
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Oita, Japan, 870-0921
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Okayama, Japan, 701-0304
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Okayama, Japan, 702-8055
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Okayama, Japan, 711-0921
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Okinawa, Japan, 901-2393
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Okinawa, Japan, 901-2121
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Okinawa, Japan, 901-2132
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Okinawa, Japan, 904-2143
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Okinawa, Japan, 904-2293
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Osaka, Japan, 596-8501
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Osaka, Japan, 576-0016
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Osaka, Japan, 530-0001
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Osaka, Japan, 533-0024
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Osaka, Japan, 559-0012
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Osaka, Japan, 564-0013
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Osaka, Japan, 576-0041
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Osaka, Japan, 591-8037
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Osaka, Japan, 591-8555
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Saitama, Japan, 349-1105
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Shizuoka, Japan, 430-8525
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Shizuoka, Japan, 420-8527
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Tochigi, Japan, 320-0065
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Tokyo, Japan, 103-0027
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Tokyo, Japan, 103-0028
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Tokyo, Japan, 104-8560
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Tokyo, Japan, 120-0033
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Tokyo, Japan, 198-0042
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Tokyo, Japan, 204-8585
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Tokyo, Japan, 194-0023
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Tokyo, Japan, 134-0083
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Tokyo, Japan, 158-8531
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Toyama, Japan, 937-0042
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Toyama, Japan, 938-8502
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Wakayama, Japan, 640-8558
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Yamagata, Japan, 990-8533
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Yamanashi, Japan, 400-0031
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Yamanashi, Japan, 400-8506
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Bucheon city, Gyenggi-do, Korea, Republic of, 420-767
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of, 361-763
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Gyeonggi-do, Korea, Republic of, 463-707
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Gyeonggi-do, Korea, Republic of, 410-719
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Gyeonggi-do, Korea, Republic of, 431-796
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Incheon, Korea, Republic of, 405-760
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Incheon, Korea, Republic of, 403-720
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Jeonju-si, Korea, Republic of, 561-712
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Kangwon-do, Korea, Republic of, 220-701
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Seoul, Korea, Republic of, 120-752
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Seoul, Korea, Republic of, 110-744
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Seoul, Korea, Republic of, 135-720
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Seoul, Korea, Republic of, 143-729
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Seoul, Korea, Republic of, 136-705
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Seoul, Korea, Republic of, 130-709
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Seoul, Korea, Republic of, 158-710
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Seoul, Korea, Republic of, 150-713
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Seoul, Korea, Republic of, 130-872
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Seoul, Korea, Republic of, 156-755
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Seoul, Korea, Republic of, 156-707
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Seoul, Korea, Republic of, 134-791
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Seoul, Korea, Republic of, 134-814
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Suwon, Korea, Republic of, 442-723
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Alkmaar, Netherlands, 1815 JD
- GSK Investigational Site
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Almelo, Netherlands, 7609 PP
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Almelo, Netherlands, 7606 SB
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Assen, Netherlands, 9401 RK
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Beek, Netherlands, 6191 JW
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Breda, Netherlands, 4818 CK
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Den Bosch, Netherlands, 5223 GZ
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Dordrecht, Netherlands, 3318 AT
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Eindhoven, Netherlands, 5623 EJ
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Enschede, Netherlands, 7513 ER
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Groningen, Netherlands, 9728 NT
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Harderwijk, Netherlands, 3844 DG
- GSK Investigational Site
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Helmond, Netherlands, 5707 HA
- GSK Investigational Site
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Hoofddorp, Netherlands, 2134 TM
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Hoorn, Netherlands, 1624 NP
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Kloosterhaar, Netherlands, 7694 AC
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Leeuwarden, Netherlands, 8934 AD
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Nieuwegein, Netherlands, 3435 CM
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Rotterdam, Netherlands, 3083 AN
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Sneek, Netherlands, 8601 ZR
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Spijkenisse, Netherlands, 3207 NB
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Veldhoven, Netherlands, 5504 DB
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Zutphen, Netherlands, 7207 AE
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Zwolle, Netherlands, 8025 AB
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Auckland, New Zealand, 1051
- GSK Investigational Site
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Dunedin, New Zealand, 9012
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Newtown, Wellington, New Zealand, 6021
- GSK Investigational Site
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Tauranga, New Zealand, 3110
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Tauranga, New Zealand, 3112
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Wellington, New Zealand, 6021
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Bodø, Norway, 8005
- GSK Investigational Site
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Fredrikstad, Norway, 1606
- GSK Investigational Site
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Hakadal, Norway, 1487
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Kløfta, Norway, 2040
- GSK Investigational Site
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Levanger, Norway, 7600
- GSK Investigational Site
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Oslo, Norway, 0953
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Stavanger, Norway, 4005
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Stavanger, Norway, 4011
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Trondheim, Norway, 7027
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Lima, Peru, Lima 1
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Lima, Peru, Lima 27
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Lima, Peru, 01
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Lima, Peru, Lima 41
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Lima, Peru, Lima 18
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Lima, Peru, Lima 32
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Lima, Peru, L 33
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Lima, Peru, L41
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Lima, Peru, Lima 14
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Lima
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Pueblo Libre, Lima, Peru, Lima 21
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San Martin de Porres, Lima, Peru, Lima 31
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San Miguel, Lima, Peru, Lima 32
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Caloocan City, Philippines, 1400
- GSK Investigational Site
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Iloilo, Philippines, 5000
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Jaro, Iloilo City, Philippines, 5000
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Pasig, Philippines, 1605
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Quezon City, Philippines, 1100
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Bialystok, Poland, 15-351
- GSK Investigational Site
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Ostrowiec Swietokrzyski, Poland, 27-400
- GSK Investigational Site
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Sopot, Poland, 81-741
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Szczecin, Poland, 71-124
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Tarnów, Poland, 33-100
- GSK Investigational Site
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Zgierz, Poland, 95-100
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Guaynabo, Puerto Rico, 00968
- GSK Investigational Site
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Mayaguez, Puerto Rico, 00680
- GSK Investigational Site
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Ponce, Puerto Rico, 00716
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San Juan, Puerto Rico, 00927
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San Juan, Puerto Rico, 00921
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Braila, Romania, 810003
- GSK Investigational Site
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Brasov, Romania, 500283
- GSK Investigational Site
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Bucharest, Romania, 020125
- GSK Investigational Site
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Comuna Alexandru Cel Bun, Romania, 617507
- GSK Investigational Site
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Constanta, Romania, 900002
- GSK Investigational Site
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Ploiesti, Romania, 100184
- GSK Investigational Site
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Ploiesti, Romania, 100379
- GSK Investigational Site
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Ramnicu Valcea, Romania, 240564
- GSK Investigational Site
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Barnaul, Russian Federation, 656038
- GSK Investigational Site
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Belgorod, Russian Federation, 308007
- GSK Investigational Site
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Blagoveshchensk, Russian Federation, 675000
- GSK Investigational Site
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Chita, Russian Federation, 672000
- GSK Investigational Site
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Chita, Russian Federation, 672090
- GSK Investigational Site
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Ekaterinburg, Russian Federation, 620109
- GSK Investigational Site
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Ivanovo, Russian Federation, 153005
- GSK Investigational Site
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Kazan, Russian Federation, 420015
- GSK Investigational Site
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Kazan, Russian Federation, 420012
- GSK Investigational Site
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Krasnodar, Russian Federation, 350012
- GSK Investigational Site
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Krasnoyarsk, Russian Federation, 660022
- GSK Investigational Site
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Moscow, Russian Federation, 127018
- GSK Investigational Site
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Moscow, Russian Federation, 119002
- GSK Investigational Site
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Novgorod, Russian Federation, 173008
- GSK Investigational Site
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Novosibirsk, Russian Federation, 630087
- GSK Investigational Site
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Petrozavodsk, Russian Federation, 185019
- GSK Investigational Site
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Pyatigorsk, Russian Federation, 357538
- GSK Investigational Site
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Ryazan, Russian Federation, 390039
- GSK Investigational Site
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Ryazan, Russian Federation, 390005
- GSK Investigational Site
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Saint-Petersburg, Russian Federation, 194354
- GSK Investigational Site
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Saratov, Russian Federation, 410053
- GSK Investigational Site
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St. Petersburg, Russian Federation, 194356
- GSK Investigational Site
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St. Petersburg, Russian Federation, 198216
- GSK Investigational Site
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Stavropol, Russian Federation, 355017
- GSK Investigational Site
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Tomsk, Russian Federation, 634050
- GSK Investigational Site
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Tomsk, Russian Federation, 634009
- GSK Investigational Site
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Ulan-Ude, Russian Federation, 670031
- GSK Investigational Site
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Ulyanovsk, Russian Federation, 432063
- GSK Investigational Site
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Vladimir, Russian Federation, 600023
- GSK Investigational Site
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Vladivostok, Russian Federation, 690002
- GSK Investigational Site
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Vladivostok, Russian Federation, 690950
- GSK Investigational Site
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Volgodonsk, Russian Federation, 347381
- GSK Investigational Site
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Voronezh, Russian Federation, 394066
- GSK Investigational Site
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Vsevolozhsk, Leningrad Region, Russian Federation, 188640
- GSK Investigational Site
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Yaroslavl, Russian Federation, 150003
- GSK Investigational Site
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Yaroslavl, Russian Federation, 150010
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Singapore, Singapore, 529889
- GSK Investigational Site
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Singapore, Singapore, 117599
- GSK Investigational Site
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Singapore, Singapore, 169856
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Singapore, Singapore, 609606
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Amanzimtoti, South Africa, 4126
- GSK Investigational Site
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Bellville, South Africa, 7530
- GSK Investigational Site
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Bloemfontein, South Africa, 9301
- GSK Investigational Site
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Boksburg North, South Africa, 1459
- GSK Investigational Site
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Cape Town, South Africa, 7572
- GSK Investigational Site
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Cape Town, South Africa, 7129
- GSK Investigational Site
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CapeTown, South Africa, 7764
- GSK Investigational Site
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Durban, South Africa, 4001
- GSK Investigational Site
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Durban, South Africa, 4091
- GSK Investigational Site
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Gatesville, South Africa, 7764
- GSK Investigational Site
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Johannesburg, South Africa, 2113
- GSK Investigational Site
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Korsten, South Africa, 6014
- GSK Investigational Site
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Mowbray, South Africa, 7700
- GSK Investigational Site
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Paarl, South Africa, 7646
- GSK Investigational Site
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Panorama, South Africa, 7500
- GSK Investigational Site
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Tygerberg, South Africa, 7505
- GSK Investigational Site
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Gauteng
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Benoni, Gauteng, South Africa, 1501
- GSK Investigational Site
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Boksburg, Gauteng, South Africa, 1459
- GSK Investigational Site
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Pretoria, Gauteng, South Africa, 0183
- GSK Investigational Site
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Val De Grace, Pretoria, Gauteng, South Africa, 0184
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Mpumalanga
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Middelburg, Mpumalanga, South Africa, 1055
- GSK Investigational Site
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(Badalona) Barcelona, Spain, 08911
- GSK Investigational Site
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(Barakaldo) Vizcaya, Spain, 48903
- GSK Investigational Site
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Alicante, Spain, 03004
- GSK Investigational Site
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Alzira/Valencia, Spain, 46600
- GSK Investigational Site
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Barcelona, Spain, 08036
- GSK Investigational Site
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Barcelona, Spain, 08035
- GSK Investigational Site
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Barcelona, Spain, 08003
- GSK Investigational Site
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Barcelona, Spain, 08041
- GSK Investigational Site
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Barcelona, Spain, 08023
- GSK Investigational Site
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Barcelona, Spain, 08028
- GSK Investigational Site
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Barcelona, Spain, 08006
- GSK Investigational Site
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Barcelona, Spain, 08017
- GSK Investigational Site
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Basurto/Bilbao, Spain, 48013
- GSK Investigational Site
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Burgos, Spain, 09006
- GSK Investigational Site
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Centelles (Barcelona), Spain, 08540
- GSK Investigational Site
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Coslada, Spain, 28822
- GSK Investigational Site
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Cáceres, Spain, 10003
- GSK Investigational Site
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Gerona, Spain, 17005
- GSK Investigational Site
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Girona, Spain, 17007
- GSK Investigational Site
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L'Hospitalet de Llobregat, Spain, 08907
- GSK Investigational Site
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La Coruña, Spain, 15006
- GSK Investigational Site
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La Coruña, Spain, 15011
- GSK Investigational Site
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La Roca Del Valles (Barcelona), Spain, 08430
- GSK Investigational Site
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Lleida, Spain, 25198
- GSK Investigational Site
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Madrid, Spain, 28006
- GSK Investigational Site
-
Madrid, Spain, 28040
- GSK Investigational Site
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Mataró, Spain, 08303
- GSK Investigational Site
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Málaga, Spain, 29010
- GSK Investigational Site
-
Mérida (Badajoz), Spain, 06800
- GSK Investigational Site
-
Oviedo, Spain, 33006
- GSK Investigational Site
-
Palma de Mallorca, Spain, 07120
- GSK Investigational Site
-
Pamplona, Spain, 31008
- GSK Investigational Site
-
Peralada( Girona), Spain, 17491
- GSK Investigational Site
-
Petrer/Alicante, Spain, 03610
- GSK Investigational Site
-
Ponferrada (León), Spain, 24411
- GSK Investigational Site
-
Pozuelo De Alarcón/Madrid, Spain, 28223
- GSK Investigational Site
-
Sabadell (Barcelona), Spain, 08208
- GSK Investigational Site
-
Sagunto/Valencia, Spain, 46520
- GSK Investigational Site
-
Salamanca, Spain, 37007
- GSK Investigational Site
-
San Juan De Alicante, Spain, 3550
- GSK Investigational Site
-
San Sebastian de los Reyes, Spain, 28702
- GSK Investigational Site
-
Santander, Spain, 39008
- GSK Investigational Site
-
Santiago de Compostela, Spain, 15706
- GSK Investigational Site
-
Sevilla, Spain, 41013
- GSK Investigational Site
-
Tarragona, Spain, 43002
- GSK Investigational Site
-
Valencia, Spain, 46017
- GSK Investigational Site
-
Valencia, Spain, 46015
- GSK Investigational Site
-
Valladolid, Spain, 47012
- GSK Investigational Site
-
Vizcaya, Spain, 48902
- GSK Investigational Site
-
Zaragoza, Spain, 50009
- GSK Investigational Site
-
-
Andalucia
-
Marbella - Málaga, Andalucia, Spain, 29603
- GSK Investigational Site
-
-
Cantabria
-
Laredo, Cantabria, Spain, 39770
- GSK Investigational Site
-
Torrelavega, Cantabria, Spain, 39300
- GSK Investigational Site
-
-
Catalonia
-
Badalona, Catalonia, Spain, 08916
- GSK Investigational Site
-
-
-
-
-
Borås, Sweden, SE-506 30
- GSK Investigational Site
-
Göteborg, Sweden, SE-413 45
- GSK Investigational Site
-
Göteborg, Sweden, SE-413 90
- GSK Investigational Site
-
Höllviken, Sweden, SE-236 32
- GSK Investigational Site
-
Linköping, Sweden, SE-587 58
- GSK Investigational Site
-
Luleå, Sweden, SE-971 89
- GSK Investigational Site
-
Stockholm, Sweden, SE-111 57
- GSK Investigational Site
-
Uppsala, Sweden, SE-752 37
- GSK Investigational Site
-
Örebro, Sweden, SE-703 62
- GSK Investigational Site
-
Östersund, Sweden, SE-831 83
- GSK Investigational Site
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-
-
-
-
Bangkok, Thailand, 10330
- GSK Investigational Site
-
Bangkok, Thailand, 10600
- GSK Investigational Site
-
Chiangmai, Thailand, 50200
- GSK Investigational Site
-
Khon Kaen, Thailand, 40002
- GSK Investigational Site
-
Muang, Thailand, 11000
- GSK Investigational Site
-
Nakhon Ratchasima, Thailand, 30000
- GSK Investigational Site
-
Nan, Thailand, 55000
- GSK Investigational Site
-
Songkla, Thailand, 90110
- GSK Investigational Site
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-
-
-
-
Ankara, Turkey, 06100
- GSK Investigational Site
-
Istanbul, Turkey, 34020
- GSK Investigational Site
-
Istanbul, Turkey, 34844
- GSK Investigational Site
-
Izmir, Turkey, 35100
- GSK Investigational Site
-
Mersin, Turkey, 33343
- GSK Investigational Site
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-
-
-
-
Kharkiv, Ukraine, 61124
- GSK Investigational Site
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Kharkiv, Ukraine, 61002
- GSK Investigational Site
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Kiev, Ukraine, 03680
- GSK Investigational Site
-
Kyiv, Ukraine, 02232
- GSK Investigational Site
-
Kyiv, Ukraine, 03680
- GSK Investigational Site
-
Kyiv, Ukraine, 03049
- GSK Investigational Site
-
Mykolayiv, Ukraine, 54003
- GSK Investigational Site
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Odesa, Ukraine, 65025
- GSK Investigational Site
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Sumy, Ukraine, 40022
- GSK Investigational Site
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Vinnytsia, Ukraine, 21000
- GSK Investigational Site
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-
-
-
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Baillieston, Glasgow, United Kingdom, G69 7AD
- GSK Investigational Site
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Bradford, United Kingdom, BD9 6RJ
- GSK Investigational Site
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Cambridge, United Kingdom, CB2 0QQ
- GSK Investigational Site
-
Chester, United Kingdom, CH2 1UL
- GSK Investigational Site
-
Crawley, United Kingdom, RH10 7DX
- GSK Investigational Site
-
Crownhill, Plymouth, United Kingdom, PL5 3JB
- GSK Investigational Site
-
Dundee, Scotland, United Kingdom, DD1 9SY
- GSK Investigational Site
-
Sidcup, Kent, United Kingdom, DA14 6LT
- GSK Investigational Site
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Stockton-on-Tees, United Kingdom, TS19 8PE
- GSK Investigational Site
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Trowbridge, United Kingdom, BA14 9AR
- GSK Investigational Site
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-
Devon
-
Exeter, Devon, United Kingdom, EX2 5DW
- GSK Investigational Site
-
-
Lanarkshire
-
Wishaw, Lanarkshire, United Kingdom, ML2 0DP
- GSK Investigational Site
-
-
Lancashire
-
Blackpool, Lancashire, United Kingdom, FY3 7EN
- GSK Investigational Site
-
-
Middlesex
-
Northwood, Middlesex, United Kingdom, HA6 2RN
- GSK Investigational Site
-
-
Tyne & Wear
-
High Heaton, Newcastle Upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
- GSK Investigational Site
-
-
Wiltshire
-
Bradford on Avon, Wiltshire, United Kingdom, BA15 1DQ
- GSK Investigational Site
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-
-
-
Alabama
-
Athens, Alabama, United States, 35611
- GSK Investigational Site
-
Birmingham, Alabama, United States, 35294
- GSK Investigational Site
-
Birmingham, Alabama, United States, 35215
- GSK Investigational Site
-
Birmingham, Alabama, United States, 35216
- GSK Investigational Site
-
Florence, Alabama, United States, 35630
- GSK Investigational Site
-
Jasper, Alabama, United States, 35501
- GSK Investigational Site
-
Mobile, Alabama, United States, 36608
- GSK Investigational Site
-
Muscle Shoals, Alabama, United States, 35662
- GSK Investigational Site
-
Sheffield, Alabama, United States, 35660
- GSK Investigational Site
-
-
Arizona
-
Chandler, Arizona, United States, 85284
- GSK Investigational Site
-
Flagstaff, Arizona, United States, 86001
- GSK Investigational Site
-
Glendale, Arizona, United States, 85306
- GSK Investigational Site
-
Peoria, Arizona, United States, 85381
- GSK Investigational Site
-
Phoenix, Arizona, United States, 85018
- GSK Investigational Site
-
Phoenix, Arizona, United States, 85032
- GSK Investigational Site
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Tucson, Arizona, United States, 85745
- GSK Investigational Site
-
Tucson, Arizona, United States, 85723
- GSK Investigational Site
-
Tucson, Arizona, United States, 85724-5023
- GSK Investigational Site
-
-
California
-
Arcadia, California, United States, 91007
- GSK Investigational Site
-
Bakersfield, California, United States, 93301
- GSK Investigational Site
-
Chula Vista, California, United States, 91910
- GSK Investigational Site
-
Encinitas, California, United States, 92024
- GSK Investigational Site
-
Escondido, California, United States, 92025
- GSK Investigational Site
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Huntington Beach, California, United States, 92647
- GSK Investigational Site
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Long Beach, California, United States, 90808
- GSK Investigational Site
-
Long Beach, California, United States, 90822
- GSK Investigational Site
-
Mission Hills, California, United States, 91345
- GSK Investigational Site
-
Modesto, California, United States, 95350
- GSK Investigational Site
-
Newport Beach, California, United States, 92663
- GSK Investigational Site
-
Palo Alto, California, United States, 94304
- GSK Investigational Site
-
Reseda, California, United States, 91335
- GSK Investigational Site
-
Riverside, California, United States, 92506
- GSK Investigational Site
-
Rolling Hills Estates, California, United States, 90274
- GSK Investigational Site
-
Sacramento, California, United States, 95821
- GSK Investigational Site
-
San Diego, California, United States, 92117
- GSK Investigational Site
-
Santa Ana, California, United States, 92705
- GSK Investigational Site
-
Santa Monica, California, United States, 90404
- GSK Investigational Site
-
Torrance, California, United States, 90505
- GSK Investigational Site
-
Tustin, California, United States, 92780
- GSK Investigational Site
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Upland, California, United States, 91786
- GSK Investigational Site
-
Vista, California, United States, 92083
- GSK Investigational Site
-
-
Colorado
-
Boulder, Colorado, United States, 80301
- GSK Investigational Site
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Colorado Springs, Colorado, United States, 80907
- GSK Investigational Site
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Fort Collins, Colorado, United States, 80538
- GSK Investigational Site
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Golden, Colorado, United States, 80401
- GSK Investigational Site
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Connecticut
-
Danbury, Connecticut, United States, 06810
- GSK Investigational Site
-
Hartford, Connecticut, United States, 06105
- GSK Investigational Site
-
New Haven, Connecticut, United States, 06520
- GSK Investigational Site
-
Stamford, Connecticut, United States, 06902
- GSK Investigational Site
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Waterbury, Connecticut, United States, 06708
- GSK Investigational Site
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West Haven, Connecticut, United States, 06516
- GSK Investigational Site
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-
Florida
-
Bay Pines, Florida, United States, 33744
- GSK Investigational Site
-
Boynton Beach, Florida, United States, 33436
- GSK Investigational Site
-
Brandon, Florida, United States, 33511
- GSK Investigational Site
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Celebration, Florida, United States, 34747
- GSK Investigational Site
-
Clearwater, Florida, United States, 33765-2616
- GSK Investigational Site
-
Clearwater, Florida, United States, 33759
- GSK Investigational Site
-
Daytona Beach, Florida, United States, 32117
- GSK Investigational Site
-
DeLand, Florida, United States, 32720
- GSK Investigational Site
-
Edgewater, Florida, United States, 32132
- GSK Investigational Site
-
Fort Lauderdale, Florida, United States, 33306
- GSK Investigational Site
-
Fort Myers, Florida, United States, 33908
- GSK Investigational Site
-
Gainesville, Florida, United States, 32608
- GSK Investigational Site
-
Hollywood, Florida, United States, 33024
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32216
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32205
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32209
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32207
- GSK Investigational Site
-
Jacksonville, Florida, United States, 32204
- GSK Investigational Site
-
Leesburg, Florida, United States, 34748
- GSK Investigational Site
-
Loxahatchee Groves, Florida, United States, 33470
- GSK Investigational Site
-
Maitland, Florida, United States, 32751
- GSK Investigational Site
-
Miami, Florida, United States, 33137
- GSK Investigational Site
-
Miami, Florida, United States, 33015
- GSK Investigational Site
-
New Port Richey, Florida, United States, 34652
- GSK Investigational Site
-
Orlando, Florida, United States, 32825
- GSK Investigational Site
-
Oviedo, Florida, United States, 32765
- GSK Investigational Site
-
Pembroke Pines, Florida, United States, 33027
- GSK Investigational Site
-
Pensacola, Florida, United States, 32503
- GSK Investigational Site
-
Ponte Vedra Beach, Florida, United States, 32081
- GSK Investigational Site
-
Port Charlotte, Florida, United States, 33952
- GSK Investigational Site
-
Port Charlotte, Florida, United States, 33980
- GSK Investigational Site
-
Port Orange, Florida, United States, 32127
- GSK Investigational Site
-
Saint Petersburg, Florida, United States, 33704
- GSK Investigational Site
-
Sarasota, Florida, United States, 34239
- GSK Investigational Site
-
Tampa, Florida, United States, 33603
- GSK Investigational Site
-
-
Georgia
-
Adairsville, Georgia, United States, 30103
- GSK Investigational Site
-
Athens, Georgia, United States, 30606
- GSK Investigational Site
-
Austell, Georgia, United States, 30106
- GSK Investigational Site
-
Columbus, Georgia, United States, 31904
- GSK Investigational Site
-
Conyers, Georgia, United States, 30094
- GSK Investigational Site
-
Decatur, Georgia, United States, 30033
- GSK Investigational Site
-
Duluth, Georgia, United States, 30096
- GSK Investigational Site
-
Gainesville, Georgia, United States, 30501
- GSK Investigational Site
-
Marietta, Georgia, United States, 30060
- GSK Investigational Site
-
Rincon, Georgia, United States, 31326
- GSK Investigational Site
-
Woodstock, Georgia, United States, 30189
- GSK Investigational Site
-
-
Idaho
-
Coeur d'Alene, Idaho, United States, 83814
- GSK Investigational Site
-
-
Illinois
-
Chicago, Illinois, United States, 60611
- GSK Investigational Site
-
Elk Grove Village, Illinois, United States, 60007
- GSK Investigational Site
-
Gillespie, Illinois, United States, 62033
- GSK Investigational Site
-
Hines, Illinois, United States, 60124
- GSK Investigational Site
-
O'Fallon, Illinois, United States, 62269
- GSK Investigational Site
-
Oak Park, Illinois, United States, 60302
- GSK Investigational Site
-
Quincy, Illinois, United States, 62301
- GSK Investigational Site
-
Winfield, Illinois, United States, 60190
- GSK Investigational Site
-
-
Indiana
-
Evansville, Indiana, United States, 47714
- GSK Investigational Site
-
Franklin, Indiana, United States, 46131
- GSK Investigational Site
-
Greenfield, Indiana, United States, 46140
- GSK Investigational Site
-
Muncie, Indiana, United States, 47303
- GSK Investigational Site
-
-
Iowa
-
Council Bluffs, Iowa, United States, 51503
- GSK Investigational Site
-
Iowa City, Iowa, United States, 52242
- GSK Investigational Site
-
-
Kansas
-
Olathe, Kansas, United States, 66061
- GSK Investigational Site
-
Topeka, Kansas, United States, 66606
- GSK Investigational Site
-
Wichita, Kansas, United States, 67218
- GSK Investigational Site
-
-
Kentucky
-
Fort Mitchell, Kentucky, United States, 41017
- GSK Investigational Site
-
Louisville, Kentucky, United States, 40218
- GSK Investigational Site
-
Paducah, Kentucky, United States, 42003
- GSK Investigational Site
-
-
Louisiana
-
Crowley, Louisiana, United States, 70526
- GSK Investigational Site
-
Lafayette, Louisiana, United States, 70508
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70115
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70112
- GSK Investigational Site
-
New Orleans, Louisiana, United States, 70119
- GSK Investigational Site
-
Shreveport, Louisiana, United States, 71103
- GSK Investigational Site
-
Sunset, Louisiana, United States, 70584
- GSK Investigational Site
-
-
Maine
-
Bangor, Maine, United States, 04401
- GSK Investigational Site
-
-
Maryland
-
Columbia, Maryland, United States, 21044
- GSK Investigational Site
-
Hollywood, Maryland, United States, 20636
- GSK Investigational Site
-
-
Massachusetts
-
Fall River, Massachusetts, United States, 02720
- GSK Investigational Site
-
North Dartmouth, Massachusetts, United States, 02747
- GSK Investigational Site
-
Pittsfield, Massachusetts, United States, 01201
- GSK Investigational Site
-
Worcester, Massachusetts, United States, 01608
- GSK Investigational Site
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48106
- GSK Investigational Site
-
Southfield, Michigan, United States, 48034
- GSK Investigational Site
-
Troy, Michigan, United States, 48085
- GSK Investigational Site
-
-
Minnesota
-
Duluth, Minnesota, United States, 55805
- GSK Investigational Site
-
Edina, Minnesota, United States, 55435
- GSK Investigational Site
-
Fridley, Minnesota, United States, 55432
- GSK Investigational Site
-
Minneapolis, Minnesota, United States, 55407
- GSK Investigational Site
-
Minneapolis, Minnesota, United States, 55402
- GSK Investigational Site
-
Rochester, Minnesota, United States, 55905
- GSK Investigational Site
-
Saint Paul, Minnesota, United States, 55130
- GSK Investigational Site
-
Woodbury, Minnesota, United States, 55125
- GSK Investigational Site
-
-
Mississippi
-
Jackson, Mississippi, United States, 39202
- GSK Investigational Site
-
-
Missouri
-
Chesterfield, Missouri, United States, 63017
- GSK Investigational Site
-
Kansas City, Missouri, United States, 64128
- GSK Investigational Site
-
Saint Charles, Missouri, United States, 63301
- GSK Investigational Site
-
Saint Louis, Missouri, United States, 63141
- GSK Investigational Site
-
-
Montana
-
Butte, Montana, United States, 59701
- GSK Investigational Site
-
Missoula, Montana, United States, 59808
- GSK Investigational Site
-
-
Nebraska
-
Fremont, Nebraska, United States, 68025
- GSK Investigational Site
-
Grand Island, Nebraska, United States, 68803
- GSK Investigational Site
-
Lincoln, Nebraska, United States, 68506
- GSK Investigational Site
-
Omaha, Nebraska, United States, 68131
- GSK Investigational Site
-
Omaha, Nebraska, United States, 68134
- GSK Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, United States, 89106
- GSK Investigational Site
-
Reno, Nevada, United States, 89503
- GSK Investigational Site
-
-
New Jersey
-
Marlton, New Jersey, United States, 08053
- GSK Investigational Site
-
Moorestown, New Jersey, United States, 08057
- GSK Investigational Site
-
Neptune, New Jersey, United States, 07753
- GSK Investigational Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States, 87108
- GSK Investigational Site
-
-
New York
-
Albany, New York, United States, 12208
- GSK Investigational Site
-
Bronx, New York, United States, 10461
- GSK Investigational Site
-
Bronx, New York, United States, 10457
- GSK Investigational Site
-
Bronxville, New York, United States, 10708
- GSK Investigational Site
-
New York, New York, United States, 10016
- GSK Investigational Site
-
New York, New York, United States, 10029
- GSK Investigational Site
-
New York, New York, United States, 10009
- GSK Investigational Site
-
Syracuse, New York, United States, 13210
- GSK Investigational Site
-
-
North Carolina
-
Asheville, North Carolina, United States, 28801
- GSK Investigational Site
-
Calabash, North Carolina, United States, 28467
- GSK Investigational Site
-
Charlotte, North Carolina, United States, 28207
- GSK Investigational Site
-
Charlotte, North Carolina, United States, 28277
- GSK Investigational Site
-
Charlotte, North Carolina, United States, 28262
- GSK Investigational Site
-
Durham, North Carolina, United States, 27710
- GSK Investigational Site
-
Elizabeth City, North Carolina, United States, 27909
- GSK Investigational Site
-
Gastonia, North Carolina, United States, 28054
- GSK Investigational Site
-
Greensboro, North Carolina, United States, 27403
- GSK Investigational Site
-
Hendersonville, North Carolina, United States, 28739
- GSK Investigational Site
-
Huntersville, North Carolina, United States, 28078
- GSK Investigational Site
-
Lexington, North Carolina, United States, 27292
- GSK Investigational Site
-
Mooresville, North Carolina, United States, 28117
- GSK Investigational Site
-
Shelby, North Carolina, United States, 28150
- GSK Investigational Site
-
Shelby, North Carolina, United States, 28152
- GSK Investigational Site
-
Tabor City, North Carolina, United States, 28463
- GSK Investigational Site
-
Whiteville, North Carolina, United States, 28472
- GSK Investigational Site
-
Wilmington, North Carolina, United States, 28401
- GSK Investigational Site
-
Winston-Salem, North Carolina, United States, 27103
- GSK Investigational Site
-
-
Ohio
-
Canton, Ohio, United States, 44718
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45231
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45245
- GSK Investigational Site
-
Cincinnati, Ohio, United States, 45220
- GSK Investigational Site
-
Columbus, Ohio, United States, 43213
- GSK Investigational Site
-
Dayton, Ohio, United States, 45459
- GSK Investigational Site
-
Marion, Ohio, United States, 43302
- GSK Investigational Site
-
Middleburg Heights, Ohio, United States, 44130
- GSK Investigational Site
-
Toledo, Ohio, United States, 43606
- GSK Investigational Site
-
Toledo, Ohio, United States, 43617
- GSK Investigational Site
-
Wooster, Ohio, United States, 44691
- GSK Investigational Site
-
-
Oregon
-
Corvallis, Oregon, United States, 97330
- GSK Investigational Site
-
Medford, Oregon, United States, 97504
- GSK Investigational Site
-
Portland, Oregon, United States, 97225
- GSK Investigational Site
-
Portland, Oregon, United States, 97239
- GSK Investigational Site
-
Portland, Oregon, United States, 97220
- GSK Investigational Site
-
-
Pennsylvania
-
Downingtown, Pennsylvania, United States, 19335
- GSK Investigational Site
-
Doylestown, Pennsylvania, United States, 18901
- GSK Investigational Site
-
Erie, Pennsylvania, United States, 16508
- GSK Investigational Site
-
Johnstown, Pennsylvania, United States, 15905
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19107
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19140
- GSK Investigational Site
-
Philadelphia, Pennsylvania, United States, 19142
- GSK Investigational Site
-
Phoenixville, Pennsylvania, United States, 19460
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15241
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15213
- GSK Investigational Site
-
Pittsburgh, Pennsylvania, United States, 15243
- GSK Investigational Site
-
Tipton, Pennsylvania, United States, 16684
- GSK Investigational Site
-
Wyomissing, Pennsylvania, United States, 19610
- GSK Investigational Site
-
-
Rhode Island
-
East Providence, Rhode Island, United States, 02914
- GSK Investigational Site
-
-
South Carolina
-
Anderson, South Carolina, United States, 29621
- GSK Investigational Site
-
Charleston, South Carolina, United States, 29406-7108
- GSK Investigational Site
-
Columbia, South Carolina, United States, 29204
- GSK Investigational Site
-
Columbia, South Carolina, United States, 29209
- GSK Investigational Site
-
Easley, South Carolina, United States, 29640
- GSK Investigational Site
-
Fort Mill, South Carolina, United States, 29707
- GSK Investigational Site
-
Gaffney, South Carolina, United States, 29340
- GSK Investigational Site
-
Gaffney, South Carolina, United States, 29341
- GSK Investigational Site
-
Greenville, South Carolina, United States, 29615
- GSK Investigational Site
-
Mount Pleasant, South Carolina, United States, 29464
- GSK Investigational Site
-
Rock Hill, South Carolina, United States, 29732
- GSK Investigational Site
-
Seneca, South Carolina, United States, 29678
- GSK Investigational Site
-
Spartanburg, South Carolina, United States, 29303
- GSK Investigational Site
-
Union, South Carolina, United States, 29379
- GSK Investigational Site
-
-
South Dakota
-
Rapid City, South Dakota, United States, 57702
- GSK Investigational Site
-
Sioux Falls, South Dakota, United States, 57108
- GSK Investigational Site
-
-
Tennessee
-
Chattanooga, Tennessee, United States, 37404
- GSK Investigational Site
-
Hendersonville, Tennessee, United States, 37075
- GSK Investigational Site
-
Johnson City, Tennessee, United States, 37601
- GSK Investigational Site
-
-
Texas
-
Corsicana, Texas, United States, 75110
- GSK Investigational Site
-
Edinburg, Texas, United States, 78539
- GSK Investigational Site
-
Fort Worth, Texas, United States, 76104
- GSK Investigational Site
-
Gonzales, Texas, United States, 78629
- GSK Investigational Site
-
Houston, Texas, United States, 77030
- GSK Investigational Site
-
Houston, Texas, United States, 77034
- GSK Investigational Site
-
Houston, Texas, United States, 77043
- GSK Investigational Site
-
Katy, Texas, United States, 77450
- GSK Investigational Site
-
Kerrville, Texas, United States, 78028
- GSK Investigational Site
-
Kingwood, Texas, United States, 77339
- GSK Investigational Site
-
Lewisville, Texas, United States, 75067
- GSK Investigational Site
-
Longview, Texas, United States, 75605
- GSK Investigational Site
-
Plano, Texas, United States, 75093
- GSK Investigational Site
-
San Antonio, Texas, United States, 78229
- GSK Investigational Site
-
San Antonio, Texas, United States, 78215
- GSK Investigational Site
-
Sealy, Texas, United States, 77474
- GSK Investigational Site
-
Sugar Land, Texas, United States, 77479
- GSK Investigational Site
-
Tomball, Texas, United States, 77375
- GSK Investigational Site
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Virginia
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Abingdon, Virginia, United States, 24210
- GSK Investigational Site
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Hampton, Virginia, United States, 23666
- GSK Investigational Site
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Lynchburg, Virginia, United States, 24501
- GSK Investigational Site
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Richmond, Virginia, United States, 23249
- GSK Investigational Site
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Richmond, Virginia, United States, 23225
- GSK Investigational Site
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Richmond, Virginia, United States, 23229
- GSK Investigational Site
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Virginia Beach, Virginia, United States, 23454
- GSK Investigational Site
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Washington
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Bellingham, Washington, United States, 98225
- GSK Investigational Site
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Everett, Washington, United States, 98208
- GSK Investigational Site
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Renton, Washington, United States, 98057
- GSK Investigational Site
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Renton, Washington, United States, 98055
- GSK Investigational Site
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Seattle, Washington, United States, 98122
- GSK Investigational Site
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Spokane Valley, Washington, United States, 99216
- GSK Investigational Site
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Tacoma, Washington, United States, 98405
- GSK Investigational Site
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Ha Noi, Vietnam, 10000
- GSK Investigational Site
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Ho Chi Minh, Vietnam, 70000
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
36 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Informed Consent: A signed and dated written informed consent prior to study participation
- Type of subject: Outpatient
- Age: Subjects 40 years of age or older at Visit 1
- Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). Surgically sterile females are defined as those with a documented hysterectomy and/or bilateral oophorectomy or tubal ligation. Post-menopausal females are defined as being amenorrhoeic for greater than 1 year with an appropriate clinical profile, e.g. age appropriate, > 45 years, in the absence of hormone replacement therapy OR Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to safety follow-up contact): Abstinence; Oral Contraceptive, either combined or progestogen alone; Injectable progestogen; Implants of levonorgestrel; Estrogenic vaginal ring; Percutaneous contraceptive patches; Intrauterine device (IUD) or intrauterine system (IUS); Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, "documented" refers to the outcome of the investigator's/designee's medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject's medical records. Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository)
- COPD Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society
- Smoking History: Current or former cigarette smokers with a history of cigarette smoking of >=10 pack-years at screening (visit 1) [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years)]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Note: Pipe and/or cigar use cannot be used to calculate pack-year history
- Severity of COPD symptoms: A score of >=10 on the COPD Assessment Test (CAT) at screening
- Severity of COPD Disease: A post-albuterol/salbutamol FEV1/ Forced Vital Capacity (FVC) ratio of <0.70 at Screening
- Existing COPD maintenance treatment: Subject must be receiving daily maintenance treatment for their COPD for at least 3 months prior to Screening. Note: Subjects receiving only Pro re nata (PRN) COPD medications are not eligible
- History of Exacerbations: Subjects must demonstrate: a post-bronchodilator FEV1 <50% predicted normal and a documented history of >= 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% <=FEV1 < 80% predicted normal and a documented history of >= 2 moderate exacerbations or a documented history of >=1 severe COPD exacerbation (hospitalized) in the previous 12 months. Note: Percent predicted will be calculated using the European Respiratory Society Global Lung Function Initiative reference equations. Note: A documented history of a COPD exacerbation (e.g., medical record verification) is a medical record of worsening COPD symptoms that required systemic/oral corticosteroids and/or antibiotics (for a moderate exacerbation) or hospitalization (for a severe exacerbation). Prior use of antibiotics alone does not qualify as an exacerbation history unless the use was associated with treatment of worsening symptoms of COPD, such as increased dyspnea, sputum volume, or sputum purulence (color). Subject verbal reports are not acceptable
- Liver function tests: alanine aminotransferase (ALT) <2x upper limit of normal (ULN); alkaline phosphatase <=1.5xULN; bilirubin <=1.5xULN (isolated bilirubin >1.5 x ULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category
Exclusion Criteria:
- Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study
- Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history of asthma are eligible if they have a current diagnosis of COPD)
- Alpha1-antitrypsin deficiency: Subjects with Alpha1-antitrypsin deficiency as the underlying cause of COPD
- Other respiratory disorders: Subjects with active tuberculosis, lung cancer, significant bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung diseases or other active pulmonary diseases
- Lung resection: Subjects with lung volume reduction surgery within the 12 months prior to Screening
- Risk Factors for Pneumonia: immune suppression (e.g. human immunodeficiency virus [HIV], Lupus) or other risk factors for pneumonia (e.g. neurological disorders affecting control of the upper airway, such as Parkinson's Disease, Myasthenia Gravis). Patients at potentially high risk (e.g. very low BMI, severely malnourished, or very low FEV1) will only be included at the discretion of the Investigator
- Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 14 days prior to Screening and at least 30 days following the last dose of oral/systemic corticosteroids (if applicable). In addition, any subject that experiences pneumonia and/or moderate or severe COPD exacerbation during the run-in period will be excluded
- Other Respiratory tract infections that have not resolved at least 7 days prior to screening
- Abnormal Chest x-ray(CXR): Chest x-ray (posteroanterior and lateral) reveals evidence of pneumonia or a clinically significant abnormality not believed to be due to the presence of COPD, or another condition that would hinder the ability to detect an infiltrate on CXR (e.g. significant cardiomegaly, pleural effusion or scarring). All subjects will have a chest x-ray at Screening Visit 1 (or historical radiograph or computerised tomography (CT) scan obtained within 3 months prior to screening) that will be over-read by a central vendor. Note: Subjects who have experienced pneumonia and/or moderate or severe COPD exacerbation within 3 months of screening must provide a post pneumonia/exacerbation chest x-ray to be over-read by the central vendor or have a chest x-ray conducted at screening. For sites in Germany: If a chest x-ray (or CT scan) within 3 months prior to Screening (Visit 1) is not available, approval to conduct a diagnostic chest x-ray will need to be obtained from the Federal Office for Radiation Protection (Bundesamt für Strahlenschutz [BfS])
- Other diseases/abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, gastrointestinal, urogenital, nervous system, musculoskeletal, skin, sensory, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled. Significant is defined as any disease that, in the opinion of the Investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study
- Unstable liver disease as defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, esophageal or gastric varices or persistent jaundice, cirrhosis, known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Note: Chronic stable hepatitis B and C are acceptable if the subject otherwise meets entry criteria
- Unstable or life threatening cardiac disease: subjects with any of the following at Screening (Visit 1) would be excluded: Myocardial infarction or unstable angina in the last 6 months; Unstable or life threatening cardiac arrhythmia requiring intervention in the last 3 months; New York Heart Association (NYHA) Class IV Heart failure
- Abnormal and clinically significant 12-Lead Electrocardiogram (ECG) finding: Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. The Principal Investigator will determine the clinical significance of each abnormal ECG finding in relation to the subject's medical history and exclude subjects who would be at undue risk by participating in the trial. An abnormal and clinically significant finding that would preclude a subject from entering the trial is defined as a 12-lead tracing that is interpreted as, but not limited to, any of the following: atrial fibrillation (AF) with rapid ventricular rate >120 beats per minute); sustained or nonsustained ventricular tachycardia (VT); Second degree heart block Mobitz type II and third degree heart block (unless pacemaker or defibrillator had been inserted); QT interval corrected for heart rate (QTcF) >=500 milliseconds (msec) in patients with QRS <120 msec and QTcF >=530 msec in patients with QRS >=120 msec
- Contraindications: A history of allergy or hypersensitivity to any corticosteroid, anticholinergic/muscarinic receptor antagonist, beta2-agonist, lactose/milk protein or magnesium stearate or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the Investigator contraindicates study participation
- Cancer: Subjects with carcinoma that has not been in complete remission for at least 5 years. Subjects who have had carcinoma in situ of the cervix, squamous cell carcinoma and basal cell carcinoma of the skin would not be excluded based on the 5 year waiting period if the subject has been considered cured by treatment
- Oxygen therapy: Use of long-term oxygen therapy (LTOT) described as resting oxygen therapy >3 Liter/minute (L/min) (Oxygen use =<3L/min flow is not exclusionary)
- Medication prior to spirometry: Subjects who are medically unable to withhold their albuterol/salbutamol for the 4-hour period required prior to spirometry testing at each study visit
- Pulmonary rehabilitation: Subjects who have participated in the acute phase of a Pulmonary Rehabilitation Program within 4 weeks prior to Screening or subjects who plan to enter the acute phase of a Pulmonary Rehabilitation Program during the study. Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program are not excluded
- Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug abuse within the last 2 years
- Non-compliance: Subjects at risk of non-compliance, or unable to comply with the study procedures. Any infirmity, disability, or geographic location that would limit compliance for scheduled visits
- Questionable validity of consent: Subjects with a history of psychiatric disease, intellectual deficiency, poor motivation or other conditions that will limit the validity of informed consent to participate in the study
- Affiliation with investigator site: Study investigators, sub-investigators, study coordinators, employees of a participating investigator or study site, or immediate family members of the aforementioned that is involved with this study
- Inability to read: In the opinion of the Investigator, any subject who is unable to read and/or would not be able to complete study related materials
- Medication prior to screening: Use of the following medications within the following time intervals prior to Screening (Visit 1) or during the study: Long term antibiotic therapy Subjects receiving antibiotics for long term therapy are not eligible for the study (Antibiotics are allowed for the short term treatment of an exacerbation or for short term treatment of other acute infections during the study); Systemic, Oral, parenteral corticosteroids 30 days (Except during the study oral/systemic corticosteroids may be used to treat COPD exacerbations/pneumonia) Intra-articular injections are allowed; Any other investigational drug (30 days or 5 half lives whichever is longer)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: fluticasone furoate/umeclidinium bromide/vilanterol
Eligible Subjects completing 2-weeks run-in period will receive FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg QD (morning) for a period of 52 weeks via DPI
|
FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg
|
|
Experimental: fluticasone furoate/vilanterol
Eligible Subjects completing 2-weeks run-in period will receive FF/VI 100 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI)
|
FF will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg and FF/VI 100 mcg/25 mcg
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
|
|
Experimental: umeclidinium bromide/vilanterol
Eligible Subjects completing 2-weeks run-in period will receive UMEC/VI 62.5 mcg/25 mcg QD (morning) for a treatment period of 52 weeks via DPI
|
VI will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, FF/VI 100 mcg/25 mcg and UMEC/VI 62.5 mcg/25 mcg
UMEC will be available in combination as dry powder for inhalation as FF/UMEC/VI 100 mcg/62.5 mcg/25 mcg, and UMEC/VI 62.5 mcg/25 mcg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI and FF/VI
Time Frame: Up to Week 52
|
The annual rate of moderate or severe COPD exacerbations which occurred during treatment was assessed.
Moderate exacerbations were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death).
Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death.
Analysis performed using a generalized linear model assuming a negative binomial distribution.
ITT population was used which comprised of all randomized participants, excluding those who were randomized in error.
Only those participants with non-missing co-variates were included in the analysis.
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Up to Week 52
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1), at Week 52 Comparing FF/UMEC/VI With FF/VI
Time Frame: Baseline and Week 52
|
FEV1 was defined as the amount of air a person exhales in one second.
Change from Baseline was calculated as the value of FEV1 at Week 52 minus the value at Baseline.
Baseline for trough FEV1 was defined as Day 1 (Pre-dose).
Only those participants with non-missing co-variates were included in the analysis.
The analysis was performed using a Repeated measures model with covariates of treatment group, smoking status (Screening), geographical region, visit, Baseline, Baseline by visit and treatment group by visit interactions.
|
Baseline and Week 52
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Change From Baseline in St. George's Respiratory Questionnaire for (SGRQ) Total Score at Week 52 Comparing FF/UMEC/VI With FF/VI
Time Frame: Baseline and Week 52
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SGRQ is a disease specific-questionnaire, designed to measure impact of respiratory disease and its treatment on a COPD participant's Health Related Quality of Life (HRQoL).
SGRQ contains 14 questions with total of 40 items grouped into three domains (Symptoms, Activity, and Impacts).
The overall summary score along with scores for the individual domains of symptoms, activity and impacts were assessed.
Score was calculated by summing the pre-assigned weights of answers, dividing by sum of maximum weights for items in SGRQ.
Total scores ranged from 0 to 100.
A decrease in score indicates improvement in HRQoL and higher score implies worse quality of life.
Change from Baseline was calculated as total score at Week 52 minus value at Baseline.
Baseline was defined as Day 1. Minimum clinically important difference (MCID) for this instrument is a 4-point improvement (decrease from Baseline).
Only those participants with non-missing co-variates were included in the analysis.
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Baseline and Week 52
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Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Time Frame: Up to Week 52
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This measures the number of days, to the first onset of moderate or severe exacerbations.
Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death).
Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death.
The Hazard ratio from Cox proportional hazards model with covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening), have been reported.
Only those participants with non-missing co-variates were included in the analysis.
First quartile and median time to onset are taken from the Kaplan-Meier estimates.
If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
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Up to Week 52
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Annual Rate of On-treatment Moderate/Severe Exacerbations Comparing FF/UMEC/VI With UMEC/VI in the Subset of Participants With a Blood Eosinophil Count >=150 Cells Per Microliter
Time Frame: Up to Week 52
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The annual rate of moderate or severe COPD exacerbations during the treatment, for participants with blood eosinophil count >=150 cells per microliter , has been reported.
Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death).
Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death.
Only those participants with non-missing co-variates and non-missing eosinophil, at Baseline were included in the analysis.
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Up to Week 52
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Time to First On-treatment Moderate/Severe Exacerbation Comparing FF/UMEC/VI With UMEC/VI in the Subset of Particpants With a Blood Eosinophil Count >=150 Cells Per Microliter at Baseline
Time Frame: Up to Week 52
|
This measures the number of days, to the first onset of moderate or severe exacerbations for participants with blood eosinophil count >=150 cells per microliter, at Baseline has been reported.
Moderate exacerbations, were defined as exacerbations that required treatment with oral/systemic corticosteroids and/or antibiotics (not involving hospitalization or resulting in death).
Severe exacerbations, were defined as exacerbations that required hospitalization or resulted in death.
Only those participants with non-missing co-variates and non missing eosinophils at Baseline were included in the analysis.
First quartile and median time to onset are taken from the Kaplan-Meier estimates.
If <25% (and <50%) of participants experienced the event within a treatment then Q1 (and median) time to onset are displayed as NA (not applicable) for that treatment.
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Up to Week 52
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Annual Rate of On-treatment Severe Exacerbations Comparing FF/UMEC/VI With FF/VI and With UMEC/VI
Time Frame: Up to Week 52
|
The annual rate of severe COPD exacerbations during the treatment, has been reported.
Severe exacerbations were defined as exacerbations that required hospitalization or resulted in death.
The covariates of treatment group, sex, exacerbation history (<=1, >=2 moderate/severe), smoking status (Screening), geographical region and post-bronchodilator percent predicted FEV1 (Screening) were used.
Only those participants with non-missing co-variates were included in the analysis
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Up to Week 52
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Dransfield MT, Criner GJ, Halpin DMG, Han MK, Hartley B, Kalhan R, Lange P, Lipson DA, Martinez FJ, Midwinter D, Singh D, Wise R, Kunisaki KM. Time-Dependent Risk of Cardiovascular Events Following an Exacerbation in Patients With Chronic Obstructive Pulmonary Disease: Post Hoc Analysis From the IMPACT Trial. J Am Heart Assoc. 2022 Sep 20;11(18):e024350. doi: 10.1161/JAHA.121.024350. Epub 2022 Sep 14.
- Thomashow B, Stiegler M, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Martinez FJ, Midwinter D, Singh D, Tabberer M, Wise RA, Lipson DA, Jones P. Higher COPD Assessment Test Score Associated With Greater Exacerbations Risk: A Post Hoc Analysis of the IMPACT Trial. Chronic Obstr Pulm Dis. 2022 Jan 27;9(1):68-79. doi: 10.15326/jcopdf.2021.0259.
- Bafadhel M, Barnes N, Bourke SC, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Jones CE, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Martinez FJ, Wise R, Singh D. A single blood eosinophil count measurement is as good as two for prediction of ICS treatment response in the IMPACT trial. Eur Respir J. 2021 Sep 23;58(3):2004522. doi: 10.1183/13993003.04522-2020. Print 2021 Sep. No abstract available.
- Singh D, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Lange P, Lettis S, Lipson DA, Mannino D, Martin N, Martinez FJ, Miller BE, Wise R, Zhu CQ, Lomas D. InforMing the PAthway of COPD Treatment (IMPACT) trial: fibrinogen levels predict risk of moderate or severe exacerbations. Respir Res. 2021 Apr 28;22(1):130. doi: 10.1186/s12931-021-01706-y.
- Halpin DMG, Criner GJ, Dransfield MT, Han MK, Hartley B, Harvey C, Jones CE, Kato M, Lange P, Lettis S, Lomas DA, Martinez FJ, Martin N, Singh D, Wise R, Zheng J, Lipson DA. Triple Versus Dual Combination Therapy in Chronic Obstructive Pulmonary Disease in Asian Countries: Analysis of the IMPACT Trial. Pulm Ther. 2021 Jun;7(1):101-118. doi: 10.1007/s41030-020-00136-3. Epub 2020 Nov 17.
- Bourdin A, Criner G, Devouassoux G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kalhan R, Lange P, Lettis S, Lipson DA, Lomas DA, Echave-Sustaeta Maria-Tome JM, Martin N, Martinez FJ, Quasny H, Sail L, Siler TM, Singh D, Thomashow B, Watz H, Wise R, Hanania NA. InforMing the PAthway of COPD Treatment (IMPACT Trial) Single-Inhaler Triple Therapy (Fluticasone Furoate/Umeclidinium/Vilanterol) Versus Fluticasone Furoate/Vilanterol and Umeclidinium/Vilanterol in Patients With COPD: Analysis of the Western Europe and North America Regions. Chronic Obstr Pulm Dis. 2021 Jan;8(1):76-90. doi: 10.15326/jcopdf.2020.0158.
- Zheng J, Zhong N, Wang C, Wei LP, Zhou XD, Zhao L, Dong Yuan Y, He B, Wu B, Du X, Song J, Lipson DA. Single inhaler triple therapy (FF/UMEC/VI) versus FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the China cohort in the IMPACT trial. Curr Med Res Opin. 2021 Jan;37(1):145-155. doi: 10.1080/03007995.2020.1844646. Epub 2020 Dec 7.
- Marin JM, Mateos L, Roldan J, Echave-Sustaeta JM, Pascual-Guardia S, Pardo MV, Velasco B, Jones CE, Kilbride S, Lipson DA. Efficacy of FF/UMEC/VI compared with FF/VI and UMEC/VI in patients with COPD: subgroup analysis of the Spain cohort in IMPACT. Ther Adv Respir Dis. 2020 Jan-Dec;14:1753466620963021. doi: 10.1177/1753466620963021.
- Hanania NA, Mannino DM, Criner GJ, Dransfield MT, Han MK, Jones CE, Kilbride S, Lomas DA, Martin N, Martinez FJ, Singh D, Wise RA, Halpin DMG, Lima R, Lipson DA. Effect of Age on the Efficacy and Safety of Once-Daily Single-Inhaler Triple-Therapy Fluticasone Furoate/Umeclidinium/Vilanterol in Patients With COPD: A Post Hoc Analysis of the Informing the Pathway of COPD Treatment Trial. Chest. 2021 Mar;159(3):985-995. doi: 10.1016/j.chest.2020.09.253. Epub 2020 Oct 5.
- Tabberer M, Jones CE, Kilbride S, Halpin DMG, Lomas DA, Pascoe S, Singh D, Wise RA, Criner GJ, Lange P, Dransfield MT, Han MK, Martinez FJ, Kaisermann MC, Lipson DA. Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study. Adv Ther. 2020 Sep;37(9):3775-3790. doi: 10.1007/s12325-020-01409-8. Epub 2020 Jul 9. Erratum In: Adv Ther. 2022 Mar;39(3):1446.
- Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S, Lange P, Lettis S, Lipson DA, Lomas DA, Martin N, Wise RA, Singh D, Martinez FJ. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study. A Randomized, Double-Blind, Multicenter Clinical Trial. Am J Respir Crit Care Med. 2020 Nov 1;202(9):1237-1243. doi: 10.1164/rccm.201912-2478OC.
- Day NC, Kumar S, Criner G, Dransfield M, Halpin DMG, Han MK, Jones CE, Kaisermann MC, Kilbride S, Lange P, Lomas DA, Martin N, Martinez FJ, Singh D, Wise R, Lipson DA. Single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol versus fluticasone furoate/vilanterol and umeclidinium/vilanterol in patients with COPD: results on cardiovascular safety from the IMPACT trial. Respir Res. 2020 Jun 5;21(1):139. doi: 10.1186/s12931-020-01398-w.
- Bogart MR, Hopson SD, Shih HC, Stanford RH, Coutinho AD. COPD exacerbation costs in the IMPACT study: a within-trial analysis. Am J Manag Care. 2020 May 1;26(5):e150-e154. doi: 10.37765/ajmc.2020.43157.
- Halpin DMG, Dransfield MT, Han MK, Jones CE, Kilbride S, Lange P, Lipson DA, Lomas DA, Martinez FJ, Pascoe S, Singh D, Wise R, Criner GJ. The effect of exacerbation history on outcomes in the IMPACT trial. Eur Respir J. 2020 May 21;55(5):1901921. doi: 10.1183/13993003.01921-2019. Print 2020 May. Erratum In: Eur Respir J. 2020 Jun 18;55(6):
- Lipson DA, Crim C, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Lettis S, Manchester P, Martin N, Midwinter D, Morris A, Pascoe SJ, Singh D, Wise RA, Martinez FJ. Reduction in All-Cause Mortality with Fluticasone Furoate/Umeclidinium/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Am J Respir Crit Care Med. 2020 Jun 15;201(12):1508-1516. doi: 10.1164/rccm.201911-2207OC.
- Ismaila AS, Risebrough N, Schroeder M, Shah D, Martin A, Goodall EC, Ndirangu K, Criner G, Dransfield M, Halpin DM, Han MK, Lomas DA. Cost-Effectiveness Of Once-Daily Single-Inhaler Triple Therapy In COPD: The IMPACT Trial. Int J Chron Obstruct Pulmon Dis. 2019 Nov 29;14:2681-2695. doi: 10.2147/COPD.S216072. eCollection 2019.
- Mehta R, Farrell C, Hayes S, Birk R, Okour M, Lipson DA. Population Pharmacokinetic Analysis of Fluticasone Furoate/Umeclidinium Bromide/Vilanterol in Patients with Chronic Obstructive Pulmonary Disease. Clin Pharmacokinet. 2020 Jan;59(1):67-79. doi: 10.1007/s40262-019-00794-w.
- Pascoe S, Barnes N, Brusselle G, Compton C, Criner GJ, Dransfield MT, Halpin DMG, Han MK, Hartley B, Lange P, Lettis S, Lipson DA, Lomas DA, Martinez FJ, Papi A, Roche N, van der Valk RJP, Wise R, Singh D. Blood eosinophils and treatment response with triple and dual combination therapy in chronic obstructive pulmonary disease: analysis of the IMPACT trial. Lancet Respir Med. 2019 Sep;7(9):745-756. doi: 10.1016/S2213-2600(19)30190-0. Epub 2019 Jul 4. Erratum In: Lancet Respir Med. 2021 Dec;9(12):e114.
- Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, Dransfield MT, Halpin DMG, Han MK, Jones CE, Kilbride S, Lange P, Lomas DA, Martinez FJ, Singh D, Tabberer M, Wise RA, Pascoe SJ; IMPACT Investigators. Once-Daily Single-Inhaler Triple versus Dual Therapy in Patients with COPD. N Engl J Med. 2018 May 3;378(18):1671-1680. doi: 10.1056/NEJMoa1713901. Epub 2018 Apr 18.
- Pascoe SJ, Lipson DA, Locantore N, Barnacle H, Brealey N, Mohindra R, Dransfield MT, Pavord I, Barnes N. A phase III randomised controlled trial of single-dose triple therapy in COPD: the IMPACT protocol. Eur Respir J. 2016 Aug;48(2):320-30. doi: 10.1183/13993003.02165-2015. Epub 2016 Jul 13.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 30, 2014
Primary Completion (Actual)
July 17, 2017
Study Completion (Actual)
July 17, 2017
Study Registration Dates
First Submitted
June 12, 2014
First Submitted That Met QC Criteria
June 12, 2014
First Posted (Estimate)
June 16, 2014
Study Record Updates
Last Update Posted (Actual)
October 10, 2018
Last Update Submitted That Met QC Criteria
September 11, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Lung Diseases
- Lung Diseases, Obstructive
- Pulmonary Disease, Chronic Obstructive
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anticonvulsants
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Anti-Allergic Agents
- Fluticasone
- Xhance
- Bromides
Other Study ID Numbers
- 116855
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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