Survival Of Subjects With Chronic Obstructive Pulmonary Disease (COPD)

A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Long-term Effects of Salmeterol/Fluticasone Propionate (Seretide tm) 50/500mcg BD, Salmeterol 50mcg BD and Fluticasone Propionate 500mcg BD, All Delivered Via the Diskus tm/Accuhaler tm Inhaler, on Mortality and Morbidity of Subjects With Chronic Obstructive Pulmonary Disease (COPD) Over 3 Years of Treatment

The purpose of this study is to see if fluticasone 500mcg/salmeterol 50mcg can improve the survival of subjects with COPD and also assess the long term safety profile of this drug.

Study Overview

• Status: Completed
• Conditions: Pulmonary Disease, Chronic Obstructive
• Intervention / Treatment: Drug: Salmeterol 50mcg/ Fluticasone Propionate 500mcg

Detailed Description

A multicenter, randomized, double-blind, parallel group, placebo controlled study to investigate the effects of salmeterol/fluticasone 50/500mcg bd, salmeterol 50mcg bd, and fluticasone 500mcg bd, all delivered via the DISKUS/ACCUHALER inhaler, on the survival of subjects with chronic obstructive pulmonary disease over 3 years of treatment.

• Study Type: Interventional
• Enrollment (Actual): 6228
• Phase: Phase 3

Contacts and Locations

Study Locations

• • • GSK Investigational Site
• Argentina
  • Buenos Aires, Argentina, 1272
    • GSK Investigational Site
  • Buenos Aires
    • La Plata, Buenos Aires, Argentina, 1900
      • GSK Investigational Site
    • Vicente López, Buenos Aires, Argentina, 1602
      • GSK Investigational Site
• Australia
  • New South Wales
    • Bankstown, New South Wales, Australia, 22000
      • GSK Investigational Site
    • Camperdown, New South Wales, Australia, 2050
      • GSK Investigational Site
    • North Gosford, New South Wales, Australia, 2250
      • GSK Investigational Site
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • GSK Investigational Site
    • Toorak Gardens, South Australia, Australia, 5065
      • GSK Investigational Site
  • Victoria
    • Frankston, Victoria, Australia, 3199
      • GSK Investigational Site
    • Geelong, Victoria, Australia, 3220
      • GSK Investigational Site
    • Heidelberg, Victoria, Australia, 3084
      • GSK Investigational Site
    • Melbourne, Victoria, Australia, 3004
      • GSK Investigational Site
    • Melbourne, Victoria, Australia, 3050
      • GSK Investigational Site
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • GSK Investigational Site
• Austria
  • Vienna, Austria, A-1030
    • GSK Investigational Site
  • Vienna, Austria, A-1120
    • GSK Investigational Site
  • Vienna, Austria, A-1210
    • GSK Investigational Site
  • Wels, Austria, A-4600
    • GSK Investigational Site
• Belgium
  • Bruxelles, Belgium, 1180
    • GSK Investigational Site
  • Namur, Belgium, 5000
    • GSK Investigational Site
  • Oostende, Belgium, 8400
    • GSK Investigational Site
  • Orp-Jauche, Belgium, 1350
    • GSK Investigational Site
  • Veurne, Belgium, 8630
    • GSK Investigational Site
• Brazil
  • Rio de Janeiro, Brazil, 20 551-030
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 20221-903
    • GSK Investigational Site
  • Rio de Janeiro, Brazil, 21941-590
    • GSK Investigational Site
  • São Paulo, Brazil, 05403-900
    • GSK Investigational Site
  • Rio Grande Do Sul
    • Porto Alegre, Rio Grande Do Sul, Brazil, 40110-160
      • GSK Investigational Site
    • Porto Alegre, Rio Grande Do Sul, Brazil, 90035 003
      • GSK Investigational Site
  • São Paulo
    • Santo Andre, São Paulo, Brazil, 09060-670
      • GSK Investigational Site
• Bulgaria
  • Pleven, Bulgaria, 5800
    • GSK Investigational Site
  • Russe, Bulgaria, 7000
    • GSK Investigational Site
  • Sofia, Bulgaria, 1431
    • GSK Investigational Site
  • Sofia, Bulgaria, 1202
    • GSK Investigational Site
  • Varna, Bulgaria, 9010
    • GSK Investigational Site
• Canada
  • Quebec, Canada, G1S 4L8
    • GSK Investigational Site
  • Alberta
    • Calgary, Alberta, Canada, T2N 4N1
      • GSK Investigational Site
    • Calgary, Alberta, Canada, T2V 1P9
      • GSK Investigational Site
    • Edmonton, Alberta, Canada, T6L 5X8
      • GSK Investigational Site
  • British Columbia
    • Maple Ridge, British Columbia, Canada, V2X 2L5
      • GSK Investigational Site
  • New Brunswick
    • Saint John, New Brunswick, Canada, E2M 3W5
      • GSK Investigational Site
  • Newfoundland and Labrador
    • Saint John's, Newfoundland and Labrador, Canada, A1B 3V6
      • GSK Investigational Site
  • Ontario
    • Mississauga, Ontario, Canada, L5A 1N1
      • GSK Investigational Site
    • Mississauga, Ontario, Canada, L5M 2V8
      • GSK Investigational Site
    • Scarborough, Ontario, Canada, M1B 4Z8
      • GSK Investigational Site
    • Thunder Bay, Ontario, Canada, P7A 4V7
      • GSK Investigational Site
    • Toronto, Ontario, Canada, M6H 3M2
      • GSK Investigational Site
    • Windsor, Ontario, Canada, N8X 3V6
      • GSK Investigational Site
  • Quebec
    • Montreal, Quebec, Canada, H2X 2P4
      • GSK Investigational Site
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 4J6
      • GSK Investigational Site
    • Sherbrooke, Quebec, Canada, J1H 1Z1
      • GSK Investigational Site
• Chile
  • Región De La Araucania
    • Temuco, Región De La Araucania, Chile
      • GSK Investigational Site
  • Región Metro De Santiago
    • Santiago, Región Metro De Santiago, Chile, 7500691
      • GSK Investigational Site
  • Valparaíso
    • Valparaiso, Valparaíso, Chile, 2341131
      • GSK Investigational Site
• China
  • Beijing, China, 100034
    • GSK Investigational Site
  • Beijing, China, 100037
    • GSK Investigational Site
  • Beijing, China, 100036
    • GSK Investigational Site
  • Beijing, China, 100039
    • GSK Investigational Site
  • Chongqing, China, 400037
    • GSK Investigational Site
  • Shanghai, China, 200025
    • GSK Investigational Site
  • Wangfujing, Beijing, China, 100730
    • GSK Investigational Site
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • GSK Investigational Site
  • Jiangsu
    • Nanjing, Jiangsu, China, 210002
      • GSK Investigational Site
  • Liaoning
    • Shenyang, Liaoning, China, 110015
      • GSK Investigational Site
  • Shaanxi
    • Xian, Shaanxi, China, 710061
      • GSK Investigational Site
• Croatia
  • Zagreb, Croatia, 10000
    • GSK Investigational Site
• Czech Republic
  • Hradec Kralove, Czech Republic, 500 05
    • GSK Investigational Site
  • Jaromer, Czech Republic, 551 01
    • GSK Investigational Site
  • Ostrava - Fifejdy, Czech Republic, 728 80
    • GSK Investigational Site
  • Praha 5, Czech Republic, 150 06
    • GSK Investigational Site
  • Praha 8, Czech Republic, 180 81
    • GSK Investigational Site
  • Praha 8, Czech Republic, 182 00
    • GSK Investigational Site
  • Tabor, Czech Republic, 390 19
    • GSK Investigational Site
• Denmark
  • Aarhus C, Denmark, DK-8000
    • GSK Investigational Site
  • Hvidovre, Denmark, 2650
    • GSK Investigational Site
  • Kobenhavn NV, Denmark, 2400
    • GSK Investigational Site
  • Silkenborg, Denmark, DK-8600
    • GSK Investigational Site
• Estonia
  • Kohtal-Jdrve, Estonia, 31 025
    • GSK Investigational Site
  • Tallinn, Estonia, 13419
    • GSK Investigational Site
  • Tartu, Estonia, 51014
    • GSK Investigational Site
• Finland
  • Helsinki, Finland, 00029
    • GSK Investigational Site
  • Helsinki, Finland, 00290
    • GSK Investigational Site
  • Kinkomaa, Finland, 40930
    • GSK Investigational Site
  • Lappeenranta, Finland, 53130
    • GSK Investigational Site
  • Lohja, Finland, 08200
    • GSK Investigational Site
  • Mikkeli, Finland, 50100
    • GSK Investigational Site
  • Oulainen, Finland, 86300
    • GSK Investigational Site
  • Pori, Finland, 28100
    • GSK Investigational Site
  • Vantaa, Finland, 01400
    • GSK Investigational Site
• France
  • Annonay, France, 07100
    • GSK Investigational Site
  • Avrille, France, 49240
    • GSK Investigational Site
  • Bethune Cedex, France, 62408
    • GSK Investigational Site
  • Bois Guillaume, France, 76230
    • GSK Investigational Site
  • Caen Cedex, France, 14050
    • GSK Investigational Site
  • Chamalières, France, 63400
    • GSK Investigational Site
  • Cholet, France, 49300
    • GSK Investigational Site
  • Corbeil Essonne, France, 91100
    • GSK Investigational Site
  • Ferolles Attilly, France, 77150
    • GSK Investigational Site
  • Grenoble, France, 38000
    • GSK Investigational Site
  • Lille, France, 59800
    • GSK Investigational Site
  • Lomme, France, 59160
    • GSK Investigational Site
  • Marseille Cedex 20, France, 13915
    • GSK Investigational Site
  • Maurepas, France, 78310
    • GSK Investigational Site
  • Meaux, France, 77104
    • GSK Investigational Site
  • Nantes, France, 44000
    • GSK Investigational Site
  • Nimes, France, 30900
    • GSK Investigational Site
  • Nimes, France, 30000
    • GSK Investigational Site
  • Paris Cedex 04, France, 75181
    • GSK Investigational Site
  • Saint Quentin, France, 02100
    • GSK Investigational Site
  • Tarbes Cedex 09, France, 65013
    • GSK Investigational Site
  • Toulouse Cedex 9, France, 31059
    • GSK Investigational Site
  • Tours Cedex 1, France, 37000
    • GSK Investigational Site
  • Verdun, France, 55100
    • GSK Investigational Site
• Germany
  • Berlin, Germany, 10178
    • GSK Investigational Site
  • Berlin, Germany, 10559
    • GSK Investigational Site
  • Berlin, Germany, 10365
    • GSK Investigational Site
  • Berlin, Germany, 13357
    • GSK Investigational Site
  • Baden-Wuerttemberg
    • Schwetzingen, Baden-Wuerttemberg, Germany, 68723
      • GSK Investigational Site
  • Hessen
    • Darmstadt, Hessen, Germany, 64287
      • GSK Investigational Site
    • Kassel, Hessen, Germany, 34117
      • GSK Investigational Site
  • Niedersachsen
    • Hannover, Niedersachsen, Germany, 30167
      • GSK Investigational Site
  • Nordrhein-Westfalen
    • Bielefeld, Nordrhein-Westfalen, Germany, 33602
      • GSK Investigational Site
  • Schleswig-Holstein
    • Bad Segeberg, Schleswig-Holstein, Germany, 23795
      • GSK Investigational Site
• Greece
  • Athens, Greece, 15669
    • GSK Investigational Site
  • Chania, Crete, Greece, 73300
    • GSK Investigational Site
  • Heraklion, Crete, Greece, 71110
    • GSK Investigational Site
  • Heraklion, Crete, Greece, 71409
    • GSK Investigational Site
  • Kavala, Greece, 65403
    • GSK Investigational Site
  • Larisa, Greece, 41110
    • GSK Investigational Site
  • Maroussi, Athens, Greece, 11526
    • GSK Investigational Site
  • N. Efkarpia, Thessaloniki, Greece, 564 29
    • GSK Investigational Site
  • Papagos/Athens, Greece, 15669
    • GSK Investigational Site
  • Patra, Greece, 26226
    • GSK Investigational Site
  • Thessaloniki, Greece, 57010
    • GSK Investigational Site
  • Thessaloniki, Greece, 54642
    • GSK Investigational Site
• Hong Kong
  • Aberdeen, Hong Kong
    • GSK Investigational Site
  • Kowloon, Hong Kong
    • GSK Investigational Site
  • Kwun Tong, Hong Kong
    • GSK Investigational Site
  • Lai Chi kok, Hong Kong
    • GSK Investigational Site
  • Tai Po,, Hong Kong
    • GSK Investigational Site
• Hungary
  • Budapest, Hungary, 1529
    • GSK Investigational Site
  • Cegléd, Hungary, 2700
    • GSK Investigational Site
  • Dunaujvaros, Hungary, 2400
    • GSK Investigational Site
  • Szolnok, Hungary, 5004
    • GSK Investigational Site
  • Tatabanya, Hungary, 2800
    • GSK Investigational Site
  • Törökbálint, Hungary, 2045
    • GSK Investigational Site
• Iceland
  • Fossvogur. Reykjavic, Iceland, 108
    • GSK Investigational Site
  • Reykjavik, Iceland, 109
    • GSK Investigational Site
• Italy
  • Emilia-Romagna
    • Ferrara, Emilia-Romagna, Italy, 44100
      • GSK Investigational Site
  • Lombardia
    • Brescia, Lombardia, Italy, 25123
      • GSK Investigational Site
    • Milano, Lombardia, Italy, 20152
      • GSK Investigational Site
    • Sesto San Giovanni (MI), Lombardia, Italy, 20099
      • GSK Investigational Site
    • Tradate (VA), Lombardia, Italy, 21049
      • GSK Investigational Site
  • Toscana
    • Pisa, Toscana, Italy, 56124
      • GSK Investigational Site
  • Veneto
    • Bussolengo (VR), Veneto, Italy, 37012
      • GSK Investigational Site
• Latvia
  • Riga, Latvia, LV 1035
    • GSK Investigational Site
  • Riga, Latvia, LV 1038
    • GSK Investigational Site
• Lithuania
  • Kaunas, Lithuania, LT-50009
    • GSK Investigational Site
• Malaysia
  • Kuala Lumpur, Malaysia, 50586
    • GSK Investigational Site
  • Kubang Kerian, Malaysia, 16150
    • GSK Investigational Site
  • Kuching, Malaysia, 93586
    • GSK Investigational Site
  • Tanjong Bungah, Malaysia, 10450
    • GSK Investigational Site
• Mexico
  • Mexico, Mexico, 14000
    • GSK Investigational Site
  • Mexico, D.F., Mexico, 06720
    • GSK Investigational Site
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44340
      • GSK Investigational Site
• Netherlands
  • Arnhem, Netherlands, 6815 AD
    • GSK Investigational Site
  • Bilthoven, Netherlands, 3723
    • GSK Investigational Site
  • Breda, Netherlands, 4819 EV
    • GSK Investigational Site
  • Dordrecht, Netherlands, 3317 NM
    • GSK Investigational Site
  • EDE, Netherlands, 6716 RP
    • GSK Investigational Site
  • Heerlen, Netherlands, 6419 PC
    • GSK Investigational Site
  • Hengelo, Netherlands, 7555 DL
    • GSK Investigational Site
  • Hoofddorp, Netherlands, 2130 AT
    • GSK Investigational Site
  • Roosendaal, Netherlands, 4708 AE
    • GSK Investigational Site
  • Terneuzen, Netherlands, 4535 PA
    • GSK Investigational Site
  • Utrecht, Netherlands, 2584 CX
    • GSK Investigational Site
  • Zwolle, Netherlands, 8025 AB
    • GSK Investigational Site
• New Zealand
  • Auckland, New Zealand, 1001
    • GSK Investigational Site
  • Auckland, New Zealand, 1701
    • GSK Investigational Site
  • Auckland, New Zealand, 1005
    • GSK Investigational Site
  • Hamilton, New Zealand, 2001
    • GSK Investigational Site
  • Tauranga, New Zealand, 3001
    • GSK Investigational Site
  • Wellington, New Zealand, 6035
    • GSK Investigational Site
  • Wellington South, New Zealand, 6002
    • GSK Investigational Site
• Norway
  • Alesund, Norway, 6026
    • GSK Investigational Site
  • Bardufoss, Norway, 9325
    • GSK Investigational Site
  • Bergen, Norway, 5053
    • GSK Investigational Site
  • Bodo, Norway, N-8092
    • GSK Investigational Site
  • Harstad, Norway, N-9480
    • GSK Investigational Site
  • Oslo, Norway, 1150
    • GSK Investigational Site
  • Oslo, Norway, N-0456
    • GSK Investigational Site
  • Oslo, Norway, N-0514
    • GSK Investigational Site
  • Oslo, Norway, N-1054
    • GSK Investigational Site
  • Sandvika, Norway, 1337
    • GSK Investigational Site
  • Skien, Norway, 3722
    • GSK Investigational Site
  • Tonsberg, Norway, N-3117
    • GSK Investigational Site
  • Trondheim, Norway, 7006
    • GSK Investigational Site
  • Volda, Norway, 6100
    • GSK Investigational Site
• Pakistan
  • Lahore, Pakistan
    • GSK Investigational Site
• Philippines
  • Cebu City, Philippines, 6000
    • GSK Investigational Site
  • Manila, Philippines, 1000
    • GSK Investigational Site
  • Manila, Philippines
    • GSK Investigational Site
  • Quezon City, Philippines, 1101
    • GSK Investigational Site
• Poland
  • Bialystok, Poland, 15-276
    • GSK Investigational Site
  • Katowice, Poland, 40-752
    • GSK Investigational Site
  • Warszawa, Poland, 01-138
    • GSK Investigational Site
  • Wroclaw, Poland, 50-449
    • GSK Investigational Site
  • Zabrze, Poland, 41-800
    • GSK Investigational Site
• Puerto Rico
  • Ponce, Puerto Rico, 731
    • GSK Investigational Site
• Romania
  • Brasov, Romania, 2200
    • GSK Investigational Site
  • Bucharest, Romania, 050159
    • GSK Investigational Site
  • Bucharest, Romania, 050098
    • GSK Investigational Site
  • Iasi, Romania, 700115
    • GSK Investigational Site
• Russian Federation
  • Moscow, Russian Federation, 105 077
    • GSK Investigational Site
  • Moscow, Russian Federation, 109240
    • GSK Investigational Site
  • Moscow, Russian Federation, 121 359
    • GSK Investigational Site
• Singapore
  • Singapore, Singapore, 119074
    • GSK Investigational Site
  • Singapore, Singapore, 169608
    • GSK Investigational Site
  • Singapore, Singapore, 308433
    • GSK Investigational Site
  • Singapore, Singapore, 238869
    • GSK Investigational Site
• Slovakia
  • Banska Bystrica, Slovakia, 974 01
    • GSK Investigational Site
  • Kralovsky Chlmec, Slovakia, 077 01
    • GSK Investigational Site
  • Nove Zamky, Slovakia, 940 34
    • GSK Investigational Site
  • Partizanske, Slovakia, 958 01
    • GSK Investigational Site
• South Africa
  • Cape Town, South Africa, 8001
    • GSK Investigational Site
  • Cape Town, South Africa, 7505
    • GSK Investigational Site
  • Mowbray, South Africa, 7700
    • GSK Investigational Site
  • Pretoria, South Africa
    • GSK Investigational Site
  • Pretoria, South Africa, 0040
    • GSK Investigational Site
  • KwaZulu- Natal
    • Durban, KwaZulu- Natal, South Africa, 4126
      • GSK Investigational Site
• Spain
  • Alicante, Spain
    • GSK Investigational Site
  • Barakaldo (Vizcaya), Spain, 48903
    • GSK Investigational Site
  • Barcelona, Spain, 08035
    • GSK Investigational Site
  • Cadiz, Spain, 11009
    • GSK Investigational Site
  • Cartagena, Spain, 30203
    • GSK Investigational Site
  • Elda, Spain, 03600
    • GSK Investigational Site
  • Guadalajara, Spain, 19002
    • GSK Investigational Site
  • La Coruña, Spain, 15006
    • GSK Investigational Site
  • Madrid, Spain, 28040
    • GSK Investigational Site
  • Madrid, Spain, 28046
    • GSK Investigational Site
  • Orihuela/Alicante, Spain, 03314
    • GSK Investigational Site
  • Santiago De Compostela, Spain, 15706
    • GSK Investigational Site
  • Valencia, Spain, 46017
    • GSK Investigational Site
  • Vigo/Pontevedra, Spain, 36200
    • GSK Investigational Site
  • Vizcaya, Spain, 48902
    • GSK Investigational Site
• Sweden
  • Boden, Sweden, SE-961 64
    • GSK Investigational Site
  • Eksjö, Sweden, SE-575 81
    • GSK Investigational Site
  • Göteborg, Sweden, SE-413 45
    • GSK Investigational Site
  • Helsingborg, Sweden, SE-251 87
    • GSK Investigational Site
  • Helsingborg, Sweden, SE-252 26
    • GSK Investigational Site
  • Lidköping, Sweden, SE-531 85
    • GSK Investigational Site
  • Trollhättan, Sweden, SE-461 85
    • GSK Investigational Site
• Taiwan
  • Kaohsiung, Taiwan, 80708
    • GSK Investigational Site
  • Taichung, Taiwan, 40705
    • GSK Investigational Site
  • Tainan, Taiwan, 704
    • GSK Investigational Site
  • Taipei, Taiwan, 112
    • GSK Investigational Site
  • Tau-Yuan County, Taiwan, 333
    • GSK Investigational Site
• Thailand
  • Bangkok, Thailand, 10330
    • GSK Investigational Site
  • ChiangMai, Thailand, 50200
    • GSK Investigational Site
• Ukraine
  • Kiev, Ukraine, 03680
    • GSK Investigational Site
• United Kingdom
  • London, United Kingdom, E1 1BB
    • GSK Investigational Site
  • Devon
    • Exeter, Devon, United Kingdom, EX2 5DW
      • GSK Investigational Site
  • Gloucestershire
    • Bristol, Gloucestershire, United Kingdom, BS16 2EW
      • GSK Investigational Site
  • Lancashire
    • Liverpool, Lancashire, United Kingdom, L9 7AL
      • GSK Investigational Site
    • Manchester, Lancashire, United Kingdom, M8 5RB
      • GSK Investigational Site
  • Northumberland
    • Newcastle Upon Tyne, Northumberland, United Kingdom, NE1 4LP
      • GSK Investigational Site
  • Oxfordshire
    • Headington, Oxfordshire, United Kingdom, OX3 7LJ
      • GSK Investigational Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35235
      • GSK Investigational Site
    • Birmingham, Alabama, United States, 35294-7340
      • GSK Investigational Site
    • Jasper, Alabama, United States, 35501
      • GSK Investigational Site
    • Mobile, Alabama, United States, 36608
      • GSK Investigational Site
    • Ozark, Alabama, United States, 36360
      • GSK Investigational Site
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • GSK Investigational Site
    • Phoenix, Arizona, United States, 85008
      • GSK Investigational Site
    • Scottsdale, Arizona, United States, 85251
      • GSK Investigational Site
  • California
    • Berkeley, California, United States, 94705
      • GSK Investigational Site
    • Burbank, California, United States, 91505
      • GSK Investigational Site
    • Encinitas, California, United States, 92024
      • GSK Investigational Site
    • Fresno, California, United States, 93710
      • GSK Investigational Site
    • Fullerton, California, United States, 92835
      • GSK Investigational Site
    • Long Beach, California, United States, 90822
      • GSK Investigational Site
    • Los Angeles, California, United States, 90048
      • GSK Investigational Site
    • Los Angeles, California, United States, 90033
      • GSK Investigational Site
    • Rancho Mirage, California, United States, 92270
      • GSK Investigational Site
    • Riverside, California, United States, 92506
      • GSK Investigational Site
    • San Diego, California, United States, 92103
      • GSK Investigational Site
    • San Diego, California, United States, 92123
      • GSK Investigational Site
    • San Diego, California, United States, 92120
      • GSK Investigational Site
    • San Diego, California, United States, 92117
      • GSK Investigational Site
    • San Diego, California, United States, 92103-6204
      • GSK Investigational Site
    • San Francisco, California, United States, 94102
      • GSK Investigational Site
    • San Luis Obispo, California, United States, 93401
      • GSK Investigational Site
    • Sepuldeva, California, United States, 91343
      • GSK Investigational Site
    • Stockton, California, United States, 95207
      • GSK Investigational Site
    • Sunnyvale, California, United States, 94086
      • GSK Investigational Site
    • Sylmar, California, United States, 91342-1495
      • GSK Investigational Site
    • Vista, California, United States, 92083
      • GSK Investigational Site
    • Walnut Creek, California, United States, 94598
      • GSK Investigational Site
  • Colorado
    • Arvada, Colorado, United States, 80002
      • GSK Investigational Site
    • Denver, Colorado, United States, 80206
      • GSK Investigational Site
    • Denver, Colorado, United States, 80218
      • GSK Investigational Site
    • Fort Collins, Colorado, United States, 80528
      • GSK Investigational Site
    • Longmont, Colorado, United States, 80501
      • GSK Investigational Site
    • Loveland, Colorado, United States, 80538
      • GSK Investigational Site
    • Pueblo, Colorado, United States, 81001
      • GSK Investigational Site
    • Wheat Ridge, Colorado, United States, 80033
      • GSK Investigational Site
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • GSK Investigational Site
    • Stamford, Connecticut, United States, 06902
      • GSK Investigational Site
  • Florida
    • Altamonte Springs, Florida, United States, 32701
      • GSK Investigational Site
    • Atlantis, Florida, United States, 33462
      • GSK Investigational Site
    • Bay Pines, Florida, United States, 33744
      • GSK Investigational Site
    • Brandon, Florida, United States, 33511
      • GSK Investigational Site
    • Clearwater, Florida, United States, 33756
      • GSK Investigational Site
    • Fort Lauderdale, Florida, United States, 33316
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32216
      • GSK Investigational Site
    • Jacksonville, Florida, United States, 32205
      • GSK Investigational Site
    • Largo, Florida, United States, 33770
      • GSK Investigational Site
    • Longwood, Florida, United States, 32779
      • GSK Investigational Site
    • Loxahatchee, Florida, United States, 33470
      • GSK Investigational Site
    • Miami, Florida, United States, 33136
      • GSK Investigational Site
    • Pace, Florida, United States, 32571
      • GSK Investigational Site
    • Palm Springs, Florida, United States, 33461
      • GSK Investigational Site
    • Pensacola, Florida, United States, 32514
      • GSK Investigational Site
    • Sarasota, Florida, United States, 34239
      • GSK Investigational Site
    • Tamarac, Florida, United States, 33321
      • GSK Investigational Site
    • Tampa, Florida, United States, 33613
      • GSK Investigational Site
    • West Palm Beach, Florida, United States, 33409
      • GSK Investigational Site
    • Zephyrhills, Florida, United States, 33540
      • GSK Investigational Site
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • GSK Investigational Site
    • Augusta, Georgia, United States, 30901
      • GSK Investigational Site
    • Blue Ridge, Georgia, United States, 30513
      • GSK Investigational Site
    • Decatur, Georgia, United States, 30033
      • GSK Investigational Site
    • Marietta, Georgia, United States, 30066
      • GSK Investigational Site
    • Rome, Georgia, United States, 30165
      • GSK Investigational Site
    • Roswell, Georgia, United States, 30076
      • GSK Investigational Site
  • Idaho
    • Coeur D'Alene, Idaho, United States, 83814
      • GSK Investigational Site
  • Illinois
    • Champaign, Illinois, United States, 61821
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60612-7323
      • GSK Investigational Site
    • Chicago, Illinois, United States, 60612-3824
      • GSK Investigational Site
    • Hines, Illinois, United States, 60141-5099
      • GSK Investigational Site
    • North Chicago, Illinois, United States, 60064
      • GSK Investigational Site
    • Peoria, Illinois, United States, 61602
      • GSK Investigational Site
  • Indiana
    • South Bend, Indiana, United States, 46617
      • GSK Investigational Site
  • Iowa
    • Dubuque, Iowa, United States, 52001
      • GSK Investigational Site
  • Kansas
    • Wichita, Kansas, United States, 67207
      • GSK Investigational Site
    • Wichita, Kansas, United States, 67208
      • GSK Investigational Site
  • Kentucky
    • Lexington, Kentucky, United States, 40536
      • GSK Investigational Site
    • Louisville, Kentucky, United States, 40215
      • GSK Investigational Site
  • Louisiana
    • Lafayette, Louisiana, United States, 70503
      • GSK Investigational Site
    • Shreveport, Louisiana, United States, 71103
      • GSK Investigational Site
    • Sunset, Louisiana, United States, 70584
      • GSK Investigational Site
  • Maine
    • Auburn, Maine, United States, 04210
      • GSK Investigational Site
  • Maryland
    • Baltimore, Maryland, United States, 21224
      • GSK Investigational Site
    • Baltimore, Maryland, United States, 21204
      • GSK Investigational Site
  • Massachusetts
    • Boston, Massachusetts, United States, 02135
      • GSK Investigational Site
    • Swansea, Massachusetts, United States, 02777
      • GSK Investigational Site
  • Michigan
    • Cadillac, Michigan, United States, 49601
      • GSK Investigational Site
    • Livonia, Michigan, United States, 48152
      • GSK Investigational Site
    • St. Joseph, Michigan, United States, 49085
      • GSK Investigational Site
    • Traverse City, Michigan, United States, 49684
      • GSK Investigational Site
  • Minnesota
    • Edina, Minnesota, United States, 55438
      • GSK Investigational Site
    • Minneapolis, Minnesota, United States, 55417
      • GSK Investigational Site
  • Mississippi
    • Jackson, Mississippi, United States, 39202
      • GSK Investigational Site
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • GSK Investigational Site
    • Jefferson City, Missouri, United States, 65109
      • GSK Investigational Site
    • Kansas City, Missouri, United States, 64108
      • GSK Investigational Site
    • St. Charles, Missouri, United States, 63301
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63141
      • GSK Investigational Site
    • St. Louis, Missouri, United States, 63110
      • GSK Investigational Site
  • Montana
    • Billings, Montana, United States, 59102
      • GSK Investigational Site
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68124
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68134
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68105
      • GSK Investigational Site
    • Omaha, Nebraska, United States, 68198-2456
      • GSK Investigational Site
  • Nevada
    • Las Vegas, Nevada, United States, 89104
      • GSK Investigational Site
  • New Hampshire
    • Gilford, New Hampshire, United States, 3249
      • GSK Investigational Site
    • Lebanon, New Hampshire, United States, 03756
      • GSK Investigational Site
  • New Jersey
    • East Orange, New Jersey, United States, 07018
      • GSK Investigational Site
    • New Brunswick, New Jersey, United States, 8901
      • GSK Investigational Site
    • Newark, New Jersey, United States, 07112
      • GSK Investigational Site
    • Summit, New Jersey, United States, 07091
      • GSK Investigational Site
    • Trenton, New Jersey, United States, 8629
      • GSK Investigational Site
  • New Mexico
    • Albuquerque, New Mexico, United States, 87108
      • GSK Investigational Site
  • New York
    • Albany, New York, United States, 12205
      • GSK Investigational Site
    • Albany, New York, United States, 12208
      • GSK Investigational Site
    • Bronxville, New York, United States, 10708
      • GSK Investigational Site
    • Brooklyn, New York, United States, 11217
      • GSK Investigational Site
    • Buffalo, New York, United States, 14221
      • GSK Investigational Site
    • Great Neck, New York, United States, 11023
      • GSK Investigational Site
    • Mineola, New York, United States, 11501
      • GSK Investigational Site
    • New York, New York, United States, 10025
      • 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, 10011
      • GSK Investigational Site
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27514
      • GSK Investigational Site
    • Charlotte, North Carolina, United States, 28207
      • GSK Investigational Site
    • Elizabeth City, North Carolina, United States, 27909
      • GSK Investigational Site
    • Greenville, North Carolina, United States, 27834
      • GSK Investigational Site
    • High Point, North Carolina, United States, 27262
      • GSK Investigational Site
    • Wilmington, North Carolina, United States, 28401
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27157
      • GSK Investigational Site
    • Winston-Salem, North Carolina, United States, 27103
      • GSK Investigational Site
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • GSK Investigational Site
    • Cincinnati, Ohio, United States, 45267-0405
      • GSK Investigational Site
    • Cleveland, Ohio, United States, 44024
      • GSK Investigational Site
    • Franklin, Ohio, United States, 45005
      • GSK Investigational Site
    • Toledo, Ohio, United States, 43614-5809
      • GSK Investigational Site
    • Toledo, Ohio, United States, 43617
      • GSK Investigational Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • GSK Investigational Site
  • Oregon
    • Lake Oswego, Oregon, United States, 97035
      • GSK Investigational Site
    • Medford, Oregon, United States, 97504
      • GSK Investigational Site
    • Portland, Oregon, United States, 97213
      • GSK Investigational Site
    • Portland, Oregon, United States, 97213-2281
      • GSK Investigational Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • GSK Investigational Site
    • Downington, Pennsylvania, United States, 19335
      • GSK Investigational Site
    • Doylestown, Pennsylvania, United States, 8901
      • GSK Investigational Site
    • Erie, Pennsylvania, United States, 16508
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19140
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19148
      • GSK Investigational Site
    • Philadelphia, Pennsylvania, United States, 19129
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15213
      • GSK Investigational Site
    • Pittsburgh, Pennsylvania, United States, 15218
      • GSK Investigational Site
    • Ridley Park, Pennsylvania, United States, 19078
      • GSK Investigational Site
  • Rhode Island
    • Cranston, Rhode Island, United States, 02920
      • GSK Investigational Site
    • East Providence, Rhode Island, United States, 02914
      • GSK Investigational Site
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • GSK Investigational Site
    • Charleston, South Carolina, United States, 29406-7108
      • GSK Investigational Site
    • Greer, South Carolina, United States, 29651
      • GSK Investigational Site
    • Simpsonville, South Carolina, United States, 29681
      • GSK Investigational Site
    • Spartanburg, South Carolina, United States, 29303
      • GSK Investigational Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • GSK Investigational Site
    • Johnson City, Tennessee, United States, 37601
      • GSK Investigational Site
    • Kingsport, Tennessee, United States, 37660
      • GSK Investigational Site
    • Milan, Tennessee, United States, 38372
      • GSK Investigational Site
    • Morristown, Tennessee, United States, 37813
      • GSK Investigational Site
  • Texas
    • Corsicana, Texas, United States, 75110
      • GSK Investigational Site
    • Houston, Texas, United States, 77030
      • GSK Investigational Site
    • Houston, Texas, United States, 77074
      • GSK Investigational Site
    • Houston, Texas, United States, 77024
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78217
      • GSK Investigational Site
    • San Antonio, Texas, United States, 78205
      • GSK Investigational Site
  • Utah
    • Salt Lake City, Utah, United States, 84102
      • GSK Investigational Site
  • Virginia
    • Chesapeake, Virginia, United States, 23320
      • GSK Investigational Site
    • Fredericksburg, Virginia, United States, 22401
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23249
      • GSK Investigational Site
    • Richmond, Virginia, United States, 23225
      • GSK Investigational Site
    • Roanoke, Virginia, United States, 24016
      • GSK Investigational Site
    • Virginia Beach, Virginia, United States, 23454
      • GSK Investigational Site
  • Washington
    • Bellingham, Washington, United States, 98226
      • GSK Investigational Site
    • Spokane, Washington, United States, 99204
      • GSK Investigational Site
    • Spokane, Washington, United States, 99202
      • GSK Investigational Site
  • West Virginia
    • Charleston, West Virginia, United States, 25304
      • GSK Investigational Site
    • Huntington, West Virginia, United States, 25701-1693
      • GSK Investigational Site
  • Wisconsin
    • La Crosse, Wisconsin, United States, 54601
      • GSK Investigational Site
    • Madison, Wisconsin, United States, 53705
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria:

• Patients with COPD and FEV1 <60% of predicted normal and baseline (pre-bronchodilator) FEV1/FVC ratio <70%.
• Current or ex-smokers with a smoking history of at least 10 pack-years.

Exclusion criteria:

• Diagnosis of other respiratory disorders (including asthma).
• Requirement for long term oxygen therapy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
All cause mortality at 3 years

Secondary Outcome Measures

Outcome Measure
Rate of moderate and severe COPD exacerbations and health status assessed by the St. George's Respiratory Questionnaire.

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Yates JC, Vestbo J; TORCH investigators. Salmeterol and fluticasone propionate and survival in chronic obstructive pulmonary disease. N Engl J Med. 2007 Feb 22;356(8):775-89. doi: 10.1056/NEJMoa063070.
• Naya IP, Tombs L, Muellerova H, Compton C, Jones PW. Long-term outcomes following first short-term clinically important deterioration in COPD. Respir Res. 2018 Nov 20;19(1):222. doi: 10.1186/s12931-018-0928-3.
• McGarvey LP, John M, Anderson JA, Zvarich M, Wise RA; TORCH Clinical Endpoint Committee. Ascertainment of cause-specific mortality in COPD: operations of the TORCH Clinical Endpoint Committee. Thorax. 2007 May;62(5):411-5. doi: 10.1136/thx.2006.072348. Epub 2007 Feb 20.
• Middleton PG. Management of patients with COPD: a comparison of the INSPIRE and TORCH studies. Am J Respir Crit Care Med. 2008 Jul 1;178(1):106; author reply 106-7. doi: 10.1164/ajrccm.178.1.106. No abstract available.
• Briggs AH, Glick HA, Lozano-Ortega G, Spencer M, Calverley PM, Jones PW, Vestbo J; TOwards a Revolution in COPD Health (TORCH) investigators. Is treatment with ICS and LABA cost-effective for COPD? Multinational economic analysis of the TORCH study. Eur Respir J. 2010 Mar;35(3):532-9. doi: 10.1183/09031936.00153108. Epub 2009 Aug 28.
• Celli BR, Thomas NE, Anderson JA, Ferguson GT, Jenkins CR, Jones PW, Vestbo J, Knobil K, Yates JC, Calverley PM. Effect of pharmacotherapy on rate of decline of lung function in chronic obstructive pulmonary disease: results from the TORCH study. Am J Respir Crit Care Med. 2008 Aug 15;178(4):332-8. doi: 10.1164/rccm.200712-1869OC. Epub 2008 May 29.
• Jenkins CR, Jones PW, Calverley PM, Celli B, Anderson JA, Ferguson GT, Yates JC, Willits LR, Vestbo J. Efficacy of salmeterol/fluticasone propionate by GOLD stage of chronic obstructive pulmonary disease: analysis from the randomised, placebo-controlled TORCH study. Respir Res. 2009 Jun 30;10(1):59. doi: 10.1186/1465-9921-10-59.
• Crim C, Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Willits LR, Yates JC, Vestbo J. Pneumonia risk in COPD patients receiving inhaled corticosteroids alone or in combination: TORCH study results. Eur Respir J. 2009 Sep;34(3):641-7. doi: 10.1183/09031936.00193908. Epub 2009 May 14.
• Ernst P, Suissa S. Pneumonia in elderly patients with chronic obstructive pulmonary disease. Curr Infect Dis Rep. 2008 May;10(3):223-8. doi: 10.1007/s11908-008-0037-4.
• Ferguson GT, Calverley PMA, Anderson JA, Jenkins CR, Jones PW, Willits LR, Yates JC, Vestbo J, Celli B. Prevalence and progression of osteoporosis in patients with COPD: results from the TOwards a Revolution in COPD Health study. Chest. 2009 Dec;136(6):1456-1465. doi: 10.1378/chest.08-3016. Epub 2009 Jul 6.
• Hanania NA. The impact of inhaled corticosteroid and long-acting beta-agonist combination therapy on outcomes in COPD. Pulm Pharmacol Ther. 2008;21(3):540-50. doi: 10.1016/j.pupt.2007.12.004. Epub 2008 Jan 6.
• Houghton CM, Lawson N, Borrill ZL, Wixon CL, Yoxall S, Langley SJ, Woodcock A, Singh D. Comparison of the effects of salmeterol/fluticasone propionate with fluticasone propionate on airway physiology in adults with mild persistent asthma. Respir Res. 2007 Jul 14;8(1):52. doi: 10.1186/1465-9921-8-52.
• Johnson M, Agusti AG, Barnes NC. Reflections on TORCH: potential mechanisms for the survival benefit of salmeterol/fluticasone propionate in COPD patients. COPD. 2008 Dec;5(6):369-75. doi: 10.1080/15412550802522924.
• Keene ON, Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Jones PW. Methods for therapeutic trials in COPD: lessons from the TORCH trial. Eur Respir J. 2009 Nov;34(5):1018-23. doi: 10.1183/09031936.00122608.
• Drummond MB, Wise RA, John M, Zvarich MT, McGarvey LP. Accuracy of death certificates in COPD: analysis from the TORCH trial. COPD. 2010 Jun;7(3):179-85. doi: 10.3109/15412555.2010.481695.
• Marchand E. Effect of pharmacotherapy on rate of decline of FEV(1) in the TORCH study. Am J Respir Crit Care Med. 2009 Mar 1;179(5):426; author reply 426-7. doi: 10.1164/ajrccm.179.5.426. No abstract available.
• Miravitlles M, Anzueto A. Insights into interventions in managing COPD patients: lessons from the TORCH and UPLIFT studies. Int J Chron Obstruct Pulmon Dis. 2009;4:185-201. Epub 2009 May 7.
• Niewoehner DE. TORCH and UPLIFT: what has been learned from the COPD "mega-trials"? COPD. 2009 Feb;6(1):1-3. doi: 10.1080/15412550902723984.
• Calverley PM, Anderson JA, Celli B, Ferguson GT, Jenkins C, Jones PW, Crim C, Willits LR, Yates JC, Vestbo J; TORCH Investigators. Cardiovascular events in patients with COPD: TORCH study results. Thorax. 2010 Aug;65(8):719-25. doi: 10.1136/thx.2010.136077.
• Salmeterol plus fluticasone fails to reduce mortality in patients with COPD. Formulary 2007;42:245-6.
• Stockley RA. Progression of chronic obstructive pulmonary disease: impact of inflammation, comorbidities and therapeutic intervention. Curr Med Res Opin. 2009 May;25(5):1235-45. doi: 10.1185/03007990902868971.
• Suissa S, Ernst P, Vandemheen KL, Aaron SD. Methodological issues in therapeutic trials of COPD. Eur Respir J. 2008 May;31(5):927-33. doi: 10.1183/09031936.00098307. Epub 2008 Jan 23.
• Vestbo J; TORCH Study Group. The TORCH (towards a revolution in COPD health) survival study protocol. Eur Respir J. 2004 Aug;24(2):206-10. doi: 10.1183/09031936.04.00120603.
• Vestbo J, Anderson JA, Calverley PM, Celli B, Ferguson GT, Jenkins C, Knobil K, Willits LR, Yates JC, Jones PW. Adherence to inhaled therapy, mortality and hospital admission in COPD. Thorax. 2009 Nov;64(11):939-43. doi: 10.1136/thx.2009.113662. Epub 2009 Aug 23.
• Paly VF, Naya I, Gunsoy NB, Driessen MT, Risebrough N, Briggs A, Ismaila AS. Long-term cost and utility consequences of short-term clinically important deterioration in patients with chronic obstructive pulmonary disease: results from the TORCH study. Int J Chron Obstruct Pulmon Dis. 2019 May 3;14:939-951. doi: 10.2147/COPD.S188898. eCollection 2019.
• Jenkins CR, Celli B, Anderson JA, Ferguson GT, Jones PW, Vestbo J, Yates JC, Calverley PM. Seasonality and determinants of moderate and severe COPD exacerbations in the TORCH study. Eur Respir J. 2012 Jan;39(1):38-45. doi: 10.1183/09031936.00194610. Epub 2011 Jul 7.
• Jones PW, Anderson JA, Calverley PM, Celli BR, Ferguson GT, Jenkins C, Yates JC, Vestbo J, Spencer MD; TORCH investigators. Health status in the TORCH study of COPD: treatment efficacy and other determinants of change. Respir Res. 2011 May 31;12(1):71. doi: 10.1186/1465-9921-12-71.
• Celli B, Vestbo J, Jenkins CR, Jones PW, Ferguson GT, Calverley PM, Yates JC, Anderson JA, Willits LR, Wise RA; Investigators of the TORCH Study. Sex differences in mortality and clinical expressions of patients with chronic obstructive pulmonary disease. The TORCH experience. Am J Respir Crit Care Med. 2011 Feb 1;183(3):317-22. doi: 10.1164/rccm.201004-0665OC. Epub 2010 Sep 2.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start: September 1, 2000
• Primary Completion (Actual): November 1, 2005
• Study Completion (Actual): November 1, 2005

Study Registration Dates

• First Submitted: December 20, 2005
• First Submitted That Met QC Criteria: December 21, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): January 20, 2017
• Last Update Submitted That Met QC Criteria: January 19, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: COPD; mortality; SERETIDE; ADVAIR; TORCH
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Adrenergic Agonists; Dermatologic Agents; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Anti-Allergic Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Fluticasone; Xhance; Salmeterol Xinafoate
• Other Study ID Numbers: SCO30003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

1. Annotated Case Report Form
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Informed Consent Form
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Clinical Study Report
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Study Protocol
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Statistical Analysis Plan
   Information identifier: SCO30003
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register