A Study Evaluating the Efficacy of Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dosed Inhaler on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

May 12, 2026 updated by: AstraZeneca

A Randomized, Double-blind, Parallel Group, Multi-center, Phase III Study to Assess the Efficacy of Budesonide, Glycopyrronium, and Formoterol Fumarate Metered Dose Inhaler Relative to Glycopyrronium and Formoterol Fumarate MDI on Cardiopulmonary Outcomes in Chronic Obstructive Pulmonary Disease (THARROS)

This study will evaluate the effect of triple ICS/LAMA/LABA therapy with BGF MDI 320/14.4/9.6 μg on cardiopulmonary outcomes relative to LAMA/LABA therapy with GFF MDI 14.4/9.6 μg in a population with COPD and elevated cardiopulmonary risk.

Study Overview

Detailed Description

This is a Phase III randomized, double-blind, parallel group, multi-center event-driven study comparing BGF MDI 320/14.4/9.6 μg BID with GFF MDI 14.4/9.6 μg BID in participants with COPD who are at risk of a cardiopulmonary event.

Study Type

Interventional

Enrollment (Estimated)

5000

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 Contact

Study Locations

      • Buenos Aires, Argentina, C1425BEN
        • Recruiting
        • Research Site
      • Buenos Aires, Argentina, C1012AAR
        • Recruiting
        • Research Site
      • Buenos Aires, Argentina, 1425
        • Recruiting
        • Research Site
      • CABA, Argentina, C1019ABS
        • Recruiting
        • Research Site
      • Capital Federal, Argentina, C1060ABN
        • Recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1414AIF
        • Recruiting
        • Research Site
      • Ciudad de Buenos Aires, Argentina, C1425AGC
        • Recruiting
        • Research Site
      • Florida, Argentina, B1602DQD
        • Recruiting
        • Research Site
      • Mar del Plata, Argentina, B7600GWV
        • Recruiting
        • Research Site
      • Mendoza, Argentina, M5500CCG
        • Recruiting
        • Research Site
      • Ranelagh, Argentina, 1886
        • Recruiting
        • Research Site
      • Rosario, Argentina, 2000
        • Recruiting
        • Research Site
      • San Fernando, Argentina, B1646EBJ
        • Recruiting
        • Research Site
      • San Juan Bautista, Argentina, 1888
        • Recruiting
        • Research Site
      • San Miguel de Tucumán, Argentina, 4000
        • Recruiting
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      • San Miguel de Tucumán, Argentina, T4000CBC
        • Recruiting
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      • Birtinya, Australia, 4575
        • Recruiting
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      • Cairns, Australia, 4870
        • Withdrawn
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      • Chermside, Australia, 4032
        • Completed
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      • Coffs Harbour, Australia, 02450
        • Recruiting
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      • Dubbo, Australia, 2830
        • Recruiting
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      • Nedlands, Australia, 6009
        • Recruiting
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      • Port Macquarie, Australia, 2444
        • Withdrawn
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      • Spearwood, Australia, 6163
        • Completed
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      • St Albans, Australia, 3021
        • Active, not recruiting
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      • St Albans, Australia, 3021
        • Recruiting
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      • Waitara, Australia, 2077
        • Recruiting
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      • Wangaratta, Australia, 3677
        • Withdrawn
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      • Bad Ischl, Austria, 4820
        • Recruiting
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      • Braunau am Inn, Austria, 5280
        • Recruiting
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      • Feldbach, Austria, 8330
        • Recruiting
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      • Graz, Austria, 8036
        • Recruiting
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      • Vienna, Austria, 1090
        • Withdrawn
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      • Belo Horizonte, Brazil, 30150-221
        • Recruiting
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      • Belo Horizonte, Brazil, 30220-140
        • Recruiting
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      • Belo Horizonte, Brazil, 30110-934
        • Withdrawn
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      • Blumenau, Brazil, 89030-101
        • Completed
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      • Brasília, Brazil, 70200-730
        • Recruiting
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      • Brasília, Brazil, 70390-700
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      • Brasília, Brazil, 70712-903
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      • Brasília, Brazil, 71681-603
        • Withdrawn
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      • Campina Grande do Sul, Brazil, 83.430-000
        • Recruiting
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      • Campinas, Brazil, 13060-080
        • Recruiting
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      • Caxias do Sul, Brazil, 95070-560
        • Withdrawn
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      • Curitiba, Brazil, 80230-130
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      • Curitiba, Brazil, 80810-050
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      • Curitiba, Brazil, 80030-110
        • Recruiting
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      • Fortaleza, Brazil, 60125-000
        • Completed
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      • Ijuí, Brazil, 98700-000
        • Recruiting
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      • Juiz de Fora, Brazil, 36033-318
        • Completed
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      • Mossoró, Brazil, 59603-020
        • Recruiting
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      • Natal, Brazil, 59020-035
        • Recruiting
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      • Niterói, Brazil, 24020-096
        • Recruiting
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      • Passo Fundo, Brazil, 99010-120
        • Recruiting
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      • Porto Alegre, Brazil, 90035-903
        • Recruiting
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      • Porto Alegre, Brazil, 91350-200
        • Recruiting
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      • Porto Alegre, Brazil, 90035074
        • Recruiting
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      • Porto Alegre, Brazil, 9061-000
        • Recruiting
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      • Recife, Brazil, 50740-465
        • Recruiting
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      • Rio de Janeiro, Brazil, 20551-030
        • Recruiting
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      • Rio de Janeiro, Brazil, 22281-100
        • Withdrawn
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      • Salvador, Brazil, 40170-130
        • Recruiting
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      • Santo André, Brazil, 09080-110
        • Recruiting
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      • Serra, Brazil, 29160-750
        • Recruiting
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      • Sorocaba, Brazil, 18040-425
        • Recruiting
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      • São Bernardo do Campo, Brazil, 09750-420
        • Recruiting
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      • São Bernardo do Campo, Brazil, 09715090
        • Recruiting
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      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
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      • São Paulo, Brazil, 05403-000
        • Recruiting
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      • São Paulo, Brazil, 04012-180
        • Recruiting
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      • Volta Redonda, Brazil, 27258-000
        • Recruiting
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      • Votuporanga, Brazil, 15501-405
        • Recruiting
        • Research Site
      • Burgas, Bulgaria, 8000
        • Recruiting
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      • Dobrich, Bulgaria, 9300
        • Withdrawn
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      • Dupnitsa, Bulgaria, 2600
        • Withdrawn
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      • Dupnitsa, Bulgaria, 2602
        • Recruiting
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      • Haskovo, Bulgaria, 6300
        • Recruiting
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      • Kozloduy, Bulgaria, 3320
        • Withdrawn
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      • Montana, Bulgaria, 3400
        • Recruiting
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      • Panagyurishte, Bulgaria, 4500
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      • Pazardzhik, Bulgaria, 4400
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      • Pernik, Bulgaria, 2300
        • Recruiting
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      • Pleven, Bulgaria, 5800
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      • Pleven, Bulgaria, 5800
        • Withdrawn
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      • Plovdiv, Bulgaria, 4003
        • Recruiting
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      • Plovdiv, Bulgaria, 4004
        • Withdrawn
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      • Plovdiv, Bulgaria, 4002
        • Recruiting
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      • Plovdiv, Bulgaria, 4023
        • Recruiting
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      • Rousse, Bulgaria, 7002
        • Recruiting
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      • Rousse, Bulgaria, 7000
        • Recruiting
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      • Sandanski, Bulgaria, 2800
        • Recruiting
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      • Sevlievo, Bulgaria, 5403
        • Withdrawn
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      • Sliven, Bulgaria, 8800
        • Recruiting
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      • Sliven, Bulgaria, 8800
        • Withdrawn
        • Research Site
      • Sofia, Bulgaria, 1000
        • Recruiting
        • Research Site
      • Sofia, Bulgaria, 1756
        • Recruiting
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      • Sofia, Bulgaria, 1202
        • Recruiting
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      • Sofia, Bulgaria, 1618
        • Recruiting
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      • Sofia, Bulgaria, 1000
        • Withdrawn
        • Research Site
      • Stara Zagora, Bulgaria, 6003
        • Recruiting
        • Research Site
      • Varna, Bulgaria, 9000
        • Withdrawn
        • Research Site
      • Varna, Bulgaria, 9000
        • Recruiting
        • Research Site
      • Vidin, Bulgaria, 3700
        • Recruiting
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      • Vratsa, Bulgaria, 3000
        • Recruiting
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      • Yambol, Bulgaria, 8600
        • Recruiting
        • Research Site
    • Alberta
      • Calgary, Alberta, Canada, T3R 1W7
        • Recruiting
        • Research Site
      • Sherwood Park, Alberta, Canada, T8L 0N2
        • Recruiting
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    • British Columbia
      • Kelowna, British Columbia, Canada, V1Y 1Z9
        • Recruiting
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      • Richmond, British Columbia, Canada, V6V 2L1
        • Recruiting
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    • Manitoba
      • Winnipeg, Manitoba, Canada, R3L 1Z5
        • Recruiting
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    • Nova Scotia
      • Sydney, Nova Scotia, Canada, B1M 0A1
        • Recruiting
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    • Ontario
      • Ajax, Ontario, Canada, L1S 2J5
        • Recruiting
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      • Guelph, Ontario, Canada, N1H 1B1
        • Recruiting
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      • Hamilton, Ontario, Canada, L8L 5G4
        • Recruiting
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      • Kingston, Ontario, Canada, K7L 2V7
        • Recruiting
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      • Kingston, Ontario, Canada, K7M 4E7
        • Recruiting
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      • Thunder Bay, Ontario, Canada, P7B 7C7
        • Recruiting
        • Research Site
      • Toronto, Ontario, Canada, M5T 3A9
        • Withdrawn
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    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
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      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
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      • Québec, Quebec, Canada, G1W 4R4
        • Recruiting
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      • Québec, Quebec, Canada, G3K 2P8
        • Completed
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      • Québec, Quebec, Canada, G1G 5X1
        • Recruiting
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      • Saint-Charles-Borromée, Quebec, Canada, J6E 2B4
        • Recruiting
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      • Trois-Rivières, Quebec, Canada, G8T 7A1
        • Recruiting
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      • Trois-Rivières, Quebec, Canada, G9A 4P3
        • Recruiting
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    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N 0W8
        • Withdrawn
        • Research Site
      • Curicó, Chile, 3341643
        • Recruiting
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      • Quillota, Chile, 2260000
        • Recruiting
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      • Santiago, Chile, 7500691
        • Recruiting
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      • Santiago, Chile, 7750495
        • Withdrawn
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      • Santiago, Chile, 7691236
        • Recruiting
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      • Talca, Chile, 3465584
        • Recruiting
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      • Temuco, Chile, 4810345
        • Recruiting
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      • Victoria, Chile, 4720097
        • Recruiting
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      • Vitacura, Chile, 7630226
        • Terminated
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      • Viña del Mar, Chile, 2540488
        • Recruiting
        • Research Site
      • Anning, China, 650000
        • Recruiting
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      • Anyang, China, 455001
        • Recruiting
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      • Baotou, China, 14010
        • Recruiting
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      • Baotou, China, 014040
        • Recruiting
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      • Beijing, China, 10730
        • Withdrawn
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      • Beijing, China, 101100
        • Terminated
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      • Changsha, China, 410005
        • Recruiting
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      • Changsha, China, 430033
        • Recruiting
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      • Changsha, China, 410015
        • Recruiting
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      • Changsha, China, 410004
        • Completed
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      • Changzhi, China, 46000
        • Recruiting
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      • Chengdu, China, 610072
        • Recruiting
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      • Chengdu, China, 610031
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      • Chengdu, China, 611130
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      • Chengdu, China, 610500
        • Recruiting
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      • Chifeng, China, 024000
        • Withdrawn
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      • Chizhou, China, 247099
        • Recruiting
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      • Chongqing, China, 400010
        • Recruiting
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      • Chongqing, China, 401320
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      • Chongqing, China, 408400
        • Recruiting
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      • Daqing, China, 163000
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      • Dazhou, China, 635000
        • Recruiting
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      • Foshan, China, 528000
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      • Fuzhou, China, 350001
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      • Guangzhou, China, 510120
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      • Guangzhou, China, 510000
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      • Guangzhou, China, 510530
        • Recruiting
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      • Guangzhou, China, 510163
        • Recruiting
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      • Guangzhou, China, 510145
        • Withdrawn
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      • Haikou, China, 570311
        • Recruiting
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      • Hangzhou, China, 310006
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      • Hefei, China, 230000
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      • Hefei, China, 230061
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      • Heze, China, 274099
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      • Hohhot, China, 750306
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      • Huizhou, China, 516001
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      • Huizhou, China, 516002
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      • Jiaozuo, China, 454002
        • Withdrawn
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      • Jinhua, China, 321099
        • Recruiting
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      • Jining, China, 272029
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      • Kaifeng, China, 475000
        • Withdrawn
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      • Langfang, China, 065000
        • Recruiting
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      • Lanzhou, China, 730000
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      • Lishui, China, 323000
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      • Liuzhou, China, 545006
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      • Nanchang, China, 330006
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      • Nanchang, China, 330009
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      • Nanjing, China, 210009
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      • Nanyang, China, 473005
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      • Pingxiang, China, 337055
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      • Qingdao, China, 266011
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      • Qingyuan, China, 511518
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      • Ruian, China, 325299
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      • Sanya, China, 572000
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      • Shanghai, China, 200025
        • Recruiting
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      • Shanghai, China, 201199
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      • Shanghai, China, 200240
        • Recruiting
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      • Shanghai, China, 200433
        • Terminated
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      • Shantou, China, 515041
        • Recruiting
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      • Shaoxing, China, 312000
        • Completed
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      • Shenyang, China, 110022
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      • Shenyang, China, 110032
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      • Shenzhen, China, 518020
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      • Shenzhen, China, 518001
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      • Shihezi, China, 832008
        • Withdrawn
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      • Shijiazhuang, China, 50051
        • Recruiting
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      • Siping, China, 136000
        • Recruiting
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      • Suining Shi, China, 629000
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      • Taicang, China, 215400
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      • Taiyuan, China, 030012
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      • Taiyuan, China, 030001
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      • Taiyuan, China, 030032
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      • Wenzhou, China, 325027
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      • Xi'an, China, 710006
        • Withdrawn
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      • Xiamen, China, 361004
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      • Xiangtan, China, 411100
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      • Xianyang, China, 750004
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      • Xingtai, China, 054899
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      • Xinxiang, China, 453002
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      • Xinxiang, China, 453100
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      • Xuzhou, China, 221000
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      • Yangzhou, China, 225001
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      • Yangzhou, China, 225000
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      • Yinchuan, China, 750001
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      • Yinchuan, China, 750004
        • Withdrawn
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      • Zaozhuang, China, 277102
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      • Zhangzhou, China, 363099
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      • Zhengzhou, China, 450000
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      • Zhengzhou, China, 450006
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      • Zhuhai, China, 519099
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      • Zhumadian, China, 463000
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      • Zhuzhou, China, 412007
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      • Zigong, China, 643000
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      • Ürümqi, China, 831118
        • Recruiting
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      • Armenia, Colombia, 630004
        • Withdrawn
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      • Barranquilla, Colombia, 080020
        • Withdrawn
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      • Bogotá, Colombia, 111411
        • Withdrawn
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      • Manizales, Colombia, 17001
        • Withdrawn
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      • Medellín, Colombia, 050025
        • Withdrawn
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      • Medellín, Colombia, 050030
        • Withdrawn
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      • Piedecuesta, Colombia, 681017
        • Withdrawn
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      • Rionegro, Colombia, 054047
        • Withdrawn
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      • Brandýs nad Labem, Czechia, 250 01
        • Recruiting
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      • Jindřichův Hradec, Czechia, 377 01
        • Recruiting
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      • Olomouc, Czechia, 772 00
        • Completed
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      • Olomouc, Czechia, 772 00
        • Active, not recruiting
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      • Ostrava, Czechia, 702 00
        • Recruiting
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      • Prague, Czechia, 110 00
        • Recruiting
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      • Prague, Czechia, 140 46
        • Recruiting
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      • Rokycany, Czechia, 337 22
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      • Tábor, Czechia, 390 03
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      • Aalborg, Denmark, 9000
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      • Esbjerg, Denmark, 6700
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      • Hvidovre, Denmark, 2650
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      • København NV, Denmark, 2400
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      • Næstved, Denmark, 4700
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      • Vejle, Denmark, 7100
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      • Helsinki, Finland, 00180
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      • Helsinki, Finland, 00980
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      • Kangasala, Finland, 36200
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      • Kuopio, Finland, 70100
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      • Turku, Finland, 20100
        • Withdrawn
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      • Aix-en-Provence, France, 13616
        • Recruiting
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      • Aurillac, France, 15000
        • Recruiting
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      • Bayonne, France, 64100
        • Recruiting
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      • Bayonne, France, 64100
        • Withdrawn
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      • Biarritz, France, 64200
        • Withdrawn
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      • Blois, France, 41016
        • Recruiting
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      • Brest, France, 29609
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      • Brest, France, 29200
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      • Cannes, France, 06414
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      • Cherbourg, France, 50102
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      • Créteil, France, 94000
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      • La Tronche, France, 38700
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      • Laval, France, 53015
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      • Le Coudray, France, 28630
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      • Lomme, France, Cedex 59462
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      • Lyon, France, 69317
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      • Marseille, France, 13015
        • Recruiting
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      • Marseille, France, 13003
        • Recruiting
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      • Mulhouse, France, 68100
        • Withdrawn
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      • Paris, France, 75679
        • Recruiting
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      • Paris, France, 75651
        • Withdrawn
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      • Pessac, France, 33604
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      • Pringy, France, 74374
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      • Quint-Fonsegrives, France, 31130
        • Recruiting
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      • Reims, France, 51092
        • Recruiting
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      • Roscoff, France, 29680
        • Terminated
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      • Strasbourg, France, 67091
        • Recruiting
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      • Vandœuvre-lès-Nancy, France, 54511
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      • Vannes, France, 56017
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      • Villeurbanne, France, 69100
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      • Ahrensburg, Germany, 22926
        • Recruiting
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      • Augsburg, Germany, 86150
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      • Bamberg, Germany, 96049
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      • Berlin, Germany, 13187
        • Recruiting
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      • Berlin, Germany, 12203
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      • Berlin, Germany, 12627
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      • Berlin, Germany, 12159
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      • Berlin, Germany, 10629
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      • Berlin, Germany, 12157
        • Recruiting
        • Research Site
      • Berlin, Germany, 10625
        • Recruiting
        • Research Site
      • Berlin, Germany, 10787
        • Recruiting
        • Research Site
      • Berlin, Germany, 10961
        • Recruiting
        • Research Site
      • Bonn, Germany, 53127
        • Withdrawn
        • Research Site
      • Bremen, Germany, 28215
        • Withdrawn
        • Research Site
      • Bremen, Germany, 28259
        • Withdrawn
        • Research Site
      • Cottbus, Germany, 03050
        • Recruiting
        • Research Site
      • Dachau, Germany, 85221
        • Terminated
        • Research Site
      • Darmstadt, Germany, 64283
        • Recruiting
        • Research Site
      • Deggingen, Germany, 73326
        • Withdrawn
        • Research Site
      • Dresden, Germany, 01069
        • Terminated
        • Research Site
      • Essen, Germany, 45127
        • Recruiting
        • Research Site
      • Essen, Germany, 45355
        • Terminated
        • Research Site
      • Frankfurt, Germany, 60596
        • Recruiting
        • Research Site
      • Hamburg, Germany, 22459
        • Recruiting
        • Research Site
      • Hamburg, Germany, 22335
        • Recruiting
        • Research Site
      • Hanover, Germany, 30449
        • Recruiting
        • Research Site
      • Hanover, Germany, D-30173
        • Recruiting
        • Research Site
      • Heidelberg, Germany, 69115
        • Withdrawn
        • Research Site
      • Ibbenbueren, Germany, 49477
        • Recruiting
        • Research Site
      • Karlsruhe, Germany, 76137
        • Terminated
        • Research Site
      • Landsberg, Germany, 86899
        • Recruiting
        • Research Site
      • Leipzig, Germany, 04299
        • Recruiting
        • Research Site
      • Leipzig, Germany, 04157
        • Recruiting
        • Research Site
      • Leipzig, Germany, 04177
        • Recruiting
        • Research Site
      • Lübeck, Germany, 23552
        • Recruiting
        • Research Site
      • Mainz, Germany, 55128
        • Recruiting
        • Research Site
      • Marburg, Germany, 35037
        • Recruiting
        • Research Site
      • Moers, Germany, 47441
        • Recruiting
        • Research Site
      • München, Germany, 80336
        • Recruiting
        • Research Site
      • Offenbach, Germany, 63065
        • Recruiting
        • Research Site
      • Offenbach, Germany, 63069
        • Withdrawn
        • Research Site
      • Peine, Germany, 31224
        • Recruiting
        • Research Site
      • Rheine, Germany, 48431
        • Recruiting
        • Research Site
      • Riesa, Germany, 01587
        • Recruiting
        • Research Site
      • Rosenheim, Germany, 83022
        • Recruiting
        • Research Site
      • Solingen, Germany, 42699
        • Completed
        • Research Site
      • Wallerfing, Germany, 94574
        • Recruiting
        • Research Site
      • Weißenburg, Germany, 91781
        • Withdrawn
        • Research Site
      • Wermsdorf, Germany, 04779
        • Recruiting
        • Research Site
      • Wiesbaden, Germany, 65183
        • Recruiting
        • Research Site
      • Wiesbaden, Germany, 65189
        • Recruiting
        • Research Site
      • Witten, Germany, 58452
        • Recruiting
        • Research Site
      • Athens, Greece, 12462
        • Recruiting
        • Research Site
      • Athens, Greece, 11527
        • Recruiting
        • Research Site
      • Athens, Greece, 17562
        • Recruiting
        • Research Site
      • Athens, Greece, 11521
        • Recruiting
        • Research Site
      • Athens, Greece, 15125
        • Recruiting
        • Research Site
      • Athens, Greece, 18547
        • Withdrawn
        • Research Site
      • Ioannina, Greece, 45500
        • Recruiting
        • Research Site
      • Pátrai, Greece, 26500
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 57010
        • Recruiting
        • Research Site
      • Thessaloniki, Greece, 57001
        • Recruiting
        • Research Site
      • Balatonfüred, Hungary, 8230
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1121
        • Recruiting
        • Research Site
      • Budapest, Hungary, 1203
        • Withdrawn
        • Research Site
      • Budapest, Hungary, 1044
        • Recruiting
        • Research Site
      • Békéscsaba, Hungary, H-5600
        • Recruiting
        • Research Site
      • Debrecen, Hungary, 4032
        • Recruiting
        • Research Site
      • Edelény, Hungary, 3780
        • Recruiting
        • Research Site
      • Encs, Hungary, 3860
        • Withdrawn
        • Research Site
      • Gyöngyös - Mátraháza, Hungary, 3200
        • Completed
        • Research Site
      • Gödöllő, Hungary, 2100
        • Withdrawn
        • Research Site
      • Hajdúnánás, Hungary, 4080
        • Recruiting
        • Research Site
      • Kalocsa, Hungary, 6300
        • Recruiting
        • Research Site
      • Komádi, Hungary, 4138
        • Recruiting
        • Research Site
      • Monor, Hungary, 2200
        • Withdrawn
        • Research Site
      • Pécs, Hungary, 7626
        • Withdrawn
        • Research Site
      • Püspökladány, Hungary, 4150
        • Recruiting
        • Research Site
      • Szeged, Hungary, 6724
        • Recruiting
        • Research Site
      • Szolnok, Hungary, 5000
        • Recruiting
        • Research Site
      • Százhalombatta, Hungary, 2440
        • Recruiting
        • Research Site
      • Székesfehérvár, Hungary, 8000
        • Withdrawn
        • Research Site
      • Tapolca, Hungary, 8300
        • Recruiting
        • Research Site
      • Törökbálint, Hungary, 2045
        • Recruiting
        • Research Site
      • Vajszló, Hungary, 7838
        • Recruiting
        • Research Site
      • Ahmedabad, India, 382421
        • Recruiting
        • Research Site
      • Ahmedabad, India, 380015
        • Recruiting
        • Research Site
      • Aligarh, India, 202002
        • Recruiting
        • Research Site
      • Belagavi, India, 590010
        • Recruiting
        • Research Site
      • Calicut, India, 673 008
        • Recruiting
        • Research Site
      • Chandigarh, India, 160012
        • Withdrawn
        • Research Site
      • Dehradun, India, 248001
        • Recruiting
        • Research Site
      • Delhi, India, 110029
        • Recruiting
        • Research Site
      • Dwārka, India, 110075
        • Recruiting
        • Research Site
      • Hyderabad, India, 500035
        • Recruiting
        • Research Site
      • Hyderabad, India, 500068
        • Recruiting
        • Research Site
      • Jaipur, India, 302017
        • Recruiting
        • Research Site
      • Kolkata, India, 700014
        • Withdrawn
        • Research Site
      • Kolkata, India, 700073
        • Recruiting
        • Research Site
      • Mangalore, India, 575003
        • Withdrawn
        • Research Site
      • Mumbai, India, 400008
        • Withdrawn
        • Research Site
      • Nagpur, India, 441108
        • Recruiting
        • Research Site
      • New Delhi, India, 110029
        • Withdrawn
        • Research Site
      • New Delhi, India, 110005
        • Withdrawn
        • Research Site
      • Pune, India, 411062
        • Recruiting
        • Research Site
      • Vijayawada, India, 520 008
        • Recruiting
        • Research Site
      • Ancona, Italy, 60100
        • Recruiting
        • Research Site
      • Florence, Italy, 50134
        • Recruiting
        • Research Site
      • Genoa, Italy, 16132
        • Recruiting
        • Research Site
      • Mestre, Italy, 30174
        • Recruiting
        • Research Site
      • Milan, Italy, 20123
        • Completed
        • Research Site
      • Naples, Italy, 80131
        • Recruiting
        • Research Site
      • Pavia, Italy, 27100
        • Recruiting
        • Research Site
      • Perugia, Italy, 06126
        • Recruiting
        • Research Site
      • Roma, Italy, 00133
        • Recruiting
        • Research Site
      • Roma, Italy, 00128
        • Recruiting
        • Research Site
      • Roma, Italy, 161
        • Recruiting
        • Research Site
      • Rome, Italy, 00189
        • Recruiting
        • Research Site
      • Siena, Italy, 53100
        • Recruiting
        • Research Site
      • Varese, Italy, 21100
        • Recruiting
        • Research Site
      • Chūōku, Japan, 103-0027
        • Recruiting
        • Research Site
      • Fujieda-shi, Japan, 426-8677
        • Recruiting
        • Research Site
      • Fukuoka, Japan, 814-0180
        • Recruiting
        • Research Site
      • Kitakyushu, Japan, 802-0052
        • Recruiting
        • Research Site
      • Kobe, Japan, 651-0072
        • Recruiting
        • Research Site
      • Kure-shi, Japan, 737-8505
        • Recruiting
        • Research Site
      • Kure-shi, Japan, 737-0193
        • Recruiting
        • Research Site
      • Kyoto, Japan, 607-8062
        • Recruiting
        • Research Site
      • Minoh, Japan, 562-0003
        • Recruiting
        • Research Site
      • Mizunami-shi, Japan, 509-6134
        • Recruiting
        • Research Site
      • Okayama, Japan, 702-8055
        • Recruiting
        • Research Site
      • Osaka, Japan, 545-8586
        • Recruiting
        • Research Site
      • Osaka, Japan, 530-0012
        • Recruiting
        • Research Site
      • Osaki-shi, Japan, 989-6183
        • Recruiting
        • Research Site
      • Sendai, Japan, 980-8574
        • Recruiting
        • Research Site
      • Shinjuku-ku, Japan, 160-8582
        • Recruiting
        • Research Site
      • Shinjuku-ku, Japan, 162-8655
        • Recruiting
        • Research Site
      • Takamatsu, Japan, 761-8073
        • Recruiting
        • Research Site
      • Yamagata, Japan, 990-8533
        • Recruiting
        • Research Site
      • Yanagawa-shi, Japan, 832-0059
        • Recruiting
        • Research Site
      • Yokohama, Japan, 234-0054
        • Recruiting
        • Research Site
      • Alor Star, Malaysia, 05460
        • Recruiting
        • Research Site
      • Kajang, Malaysia, 43000
        • Recruiting
        • Research Site
      • Kuala Lumpur, Malaysia, 50586
        • Recruiting
        • Research Site
      • Kuala Pilah, Malaysia, 72000
        • Recruiting
        • Research Site
      • Sandakan, Malaysia, 90000
        • Recruiting
        • Research Site
      • Sarawak Miri, Malaysia, 98000
        • Recruiting
        • Research Site
      • Seremban, Malaysia, 70300
        • Withdrawn
        • Research Site
      • Sibu, Malaysia, 96000
        • Recruiting
        • Research Site
      • Benito Juárez, Mexico, 03650
        • Recruiting
        • Research Site
      • Chihuahua City, Mexico, 31000
        • Recruiting
        • Research Site
      • Cuernavaca, Mexico, 62290
        • Recruiting
        • Research Site
      • Cuernavaca, Mexico, 62290
        • Withdrawn
        • Research Site
      • Culiacán, Mexico, 80020
        • Recruiting
        • Research Site
      • Guadalajara, Mexico, 44200
        • Recruiting
        • Research Site
      • Guadalajara, Mexico, 44670
        • Recruiting
        • Research Site
      • Juriquilla, Mexico, 76320
        • Recruiting
        • Research Site
      • Metepec, Mexico, 52170
        • Recruiting
        • Research Site
      • Mexico City, Mexico, 03310
        • Withdrawn
        • Research Site
      • Monterrey, Mexico, 64460
        • Recruiting
        • Research Site
      • Monterrey, Mexico, 64310
        • Recruiting
        • Research Site
      • Mérida, Mexico, 97130
        • Recruiting
        • Research Site
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • Research Site
      • Tijuana, Mexico, 22010
        • Recruiting
        • Research Site
      • Veracruz, Mexico, 91910
        • Recruiting
        • Research Site
      • Xalapa, Mexico, 91193
        • Recruiting
        • Research Site
      • Zapopan, Mexico, 45138
        • Recruiting
        • Research Site
      • Kongsberg, Norway, 3612
        • Recruiting
        • Research Site
      • Lørenskog, Norway, 1478
        • Recruiting
        • Research Site
      • Skedsmokorset, Norway, N-2020
        • Recruiting
        • Research Site
      • Trondheim, Norway, 7030
        • Not yet recruiting
        • Research Site
      • El Agustino, Peru, LIMA 10
        • Withdrawn
        • Research Site
      • Lima, Peru, 15036
        • Recruiting
        • Research Site
      • Lima, Peru, 15088
        • Recruiting
        • Research Site
      • Lima, Peru, 15046
        • Recruiting
        • Research Site
      • Lima, Peru, LIMA 21
        • Recruiting
        • Research Site
      • Lima, Peru, 15036
        • Withdrawn
        • Research Site
      • Lima, Peru, 15023
        • Withdrawn
        • Research Site
      • Lima, Peru, LIMA 01
        • Recruiting
        • Research Site
      • Lima, Peru, L18
        • Recruiting
        • Research Site
      • Lima, Peru, 15038
        • Recruiting
        • Research Site
      • Lima, Peru, 15023
        • Recruiting
        • Research Site
      • Lima, Peru, 15324
        • Recruiting
        • Research Site
      • Lima, Peru, 15102
        • Recruiting
        • Research Site
      • Lima, Peru, LIMA 1
        • Recruiting
        • Research Site
      • Lima, Peru, 15131
        • Recruiting
        • Research Site
      • Lima, Peru, 15024
        • Recruiting
        • Research Site
      • Lima, Peru, 33
        • Recruiting
        • Research Site
      • Piura, Peru, 20001
        • Recruiting
        • Research Site
      • Dagupan, Philippines, 2400
        • Recruiting
        • Research Site
      • Iloilo City, Philippines, 5000
        • Recruiting
        • Research Site
      • Las Piñas, Philippines, 1742
        • Recruiting
        • Research Site
      • Mabalacat, Philippines, 2023
        • Withdrawn
        • Research Site
      • Manadaluyong City, Philippines, 1552
        • Withdrawn
        • Research Site
      • Manila, Philippines, 1000
        • Recruiting
        • Research Site
      • Manila, Philippines, 1000
        • Withdrawn
        • Research Site
      • Marilao, Philippines, 3019
        • Recruiting
        • Research Site
      • Puerto Princesa City, Philippines, 5300
        • Recruiting
        • Research Site
      • Quezon City, Philippines, 1100
        • Recruiting
        • Research Site
      • Quezon City, Philippines, 1109
        • Recruiting
        • Research Site
      • Quezon City, Philippines, 0870
        • Recruiting
        • Research Site
      • Roxas City, Philippines, 5800
        • Withdrawn
        • Research Site
      • Tondo, Philippines, 1012
        • Recruiting
        • Research Site
      • Bialystok, Poland, 15-879
        • Recruiting
        • Research Site
      • Bialystok, Poland, 15-044
        • Recruiting
        • Research Site
      • Bydgoszcz, Poland, 85-796
        • Recruiting
        • Research Site
      • Chojnice, Poland, 89-600
        • Recruiting
        • Research Site
      • Chęciny, Poland, 26-060
        • Recruiting
        • Research Site
      • Częstochowa, Poland, 42-217
        • Recruiting
        • Research Site
      • Inowrocław, Poland, 88-100
        • Recruiting
        • Research Site
      • Karczew, Poland, 05-480
        • Recruiting
        • Research Site
      • Katowice, Poland, 40-648
        • Recruiting
        • Research Site
      • Katowice, Poland, 40-081
        • Recruiting
        • Research Site
      • Kielce, Poland, 25-426
        • Recruiting
        • Research Site
      • Kielce, Poland, 25-751
        • Withdrawn
        • Research Site
      • Krakow, Poland, 31-501
        • Recruiting
        • Research Site
      • Krakow, Poland, 31-513
        • Recruiting
        • Research Site
      • Libiąż, Poland, 32-590
        • Recruiting
        • Research Site
      • Lodz, Poland, 91-363
        • Recruiting
        • Research Site
      • Lodz, Poland, 92-003
        • Withdrawn
        • Research Site
      • Lubin, Poland, 59-300
        • Withdrawn
        • Research Site
      • Lublin, Poland, 20-601
        • Recruiting
        • Research Site
      • Lublin, Poland, 20-011
        • Recruiting
        • Research Site
      • Ostrowiec Świętokrzyski, Poland, 27-400
        • Withdrawn
        • Research Site
      • Piaseczno, Poland, 05-500
        • Recruiting
        • Research Site
      • Poznan, Poland, 60-192
        • Recruiting
        • Research Site
      • Poznan, Poland, 61-578
        • Suspended
        • Research Site
      • Płock, Poland, 09-407
        • Recruiting
        • Research Site
      • Rzeszów, Poland, 35-205
        • Recruiting
        • Research Site
      • Sieradz, Poland, 98-200
        • Suspended
        • Research Site
      • Skórzewo, Poland, 60-185
        • Recruiting
        • Research Site
      • Sochaczew, Poland, 96-500
        • Recruiting
        • Research Site
      • Sosnowiec, Poland, 41-208
        • Recruiting
        • Research Site
      • Sosnowiec, Poland, 41-200
        • Withdrawn
        • Research Site
      • Szczecin, Poland, 70-111
        • Recruiting
        • Research Site
      • Słupsk, Poland, 76-200
        • Withdrawn
        • Research Site
      • Torun, Poland, 87-100
        • Recruiting
        • Research Site
      • Ustroń, Poland, 43-450
        • Recruiting
        • Research Site
      • Warsaw, Poland, 00-215
        • Recruiting
        • Research Site
      • Warsaw, Poland, 00-719
        • Recruiting
        • Research Site
      • Warsaw, Poland, 04-501
        • Terminated
        • Research Site
      • Wroclaw, Poland, 54-239
        • Recruiting
        • Research Site
      • Wroclaw, Poland, 53-673
        • Recruiting
        • Research Site
      • Bucharest, Romania, 011461
        • Recruiting
        • Research Site
      • Bucharest, Romania, 050159
        • Recruiting
        • Research Site
      • Bucharest, Romania, 012363
        • Recruiting
        • Research Site
      • Cluj-Napoca, Romania, 400371
        • Recruiting
        • Research Site
      • Leamna de Sus, Romania, 207129
        • Recruiting
        • Research Site
      • Negreşti-Oaş, Romania, 445200
        • Recruiting
        • Research Site
      • Oradea, Romania, 410176
        • Recruiting
        • Research Site
      • Timișoara, Romania, 300310
        • Recruiting
        • Research Site
      • Timișoara, Romania, 300203
        • Recruiting
        • Research Site
      • Timișoara, Romania, 300336
        • Recruiting
        • Research Site
      • Târgu Mureş, Romania, 540098
        • Recruiting
        • Research Site
      • Belgrade, Serbia, 11000
        • Recruiting
        • Research Site
      • Belgrade, Serbia, 11080
        • Recruiting
        • Research Site
      • Belgrade, Serbia, 11040
        • Recruiting
        • Research Site
      • Kamenitz, Serbia, 21204
        • Recruiting
        • Research Site
      • Kragujevac, Serbia, 34000
        • Recruiting
        • Research Site
      • Niš, Serbia, 18108
        • Recruiting
        • Research Site
      • Novi Sad, Serbia, 21000
        • Recruiting
        • Research Site
      • Bratislava, Slovakia, 949 01
        • Recruiting
        • Research Site
      • Brezno, Slovakia, 977 01
        • Recruiting
        • Research Site
      • Humenné, Slovakia, 066 01
        • Recruiting
        • Research Site
      • Košice, Slovakia, 04022
        • Recruiting
        • Research Site
      • Kráľovský Chlmec, Slovakia, 077 01
        • Withdrawn
        • Research Site
      • Levice, Slovakia, 93401
        • Recruiting
        • Research Site
      • Prešov, Slovakia, 081 81
        • Withdrawn
        • Research Site
      • Topoľčany, Slovakia, 955 01
        • Recruiting
        • Research Site
      • Anyang-si, South Korea, 14068
        • Recruiting
        • Research Site
      • Busan, South Korea, 49201
        • Recruiting
        • Research Site
      • Daegu, South Korea, 42415
        • Recruiting
        • Research Site
      • Gwangju, South Korea, 61469
        • Withdrawn
        • Research Site
      • Jeonju, South Korea, 54907
        • Recruiting
        • Research Site
      • Seoul, South Korea, 03312
        • Recruiting
        • Research Site
      • Seoul, South Korea, 06591
        • Recruiting
        • Research Site
      • Seoul, South Korea, 04763
        • Recruiting
        • Research Site
      • Seoul, South Korea, 143-729
        • Recruiting
        • Research Site
      • Seoul, South Korea, 07061
        • Recruiting
        • Research Site
      • Seoul, South Korea, 08308
        • Terminated
        • Research Site
      • Uijeongbu-si, South Korea, 11765
        • Recruiting
        • Research Site
      • Ulsan, South Korea, 44033
        • Recruiting
        • Research Site
      • Alicante, Spain, 03010
        • Recruiting
        • Research Site
      • Badia Del Vallès, Spain, 08214
        • Recruiting
        • Research Site
      • Barakaldo, Spain, 48903
        • Withdrawn
        • Research Site
      • Barcelona, Spain, 08840
        • Recruiting
        • Research Site
      • Barcelona, Spain, 08017
        • Suspended
        • Research Site
      • Castro Urdiales, Spain, 39700
        • Recruiting
        • Research Site
      • Córdoba, Spain, 14940
        • Recruiting
        • Research Site
      • Granada, Spain, 18014
        • Recruiting
        • Research Site
      • Madrid, Spain, 28031
        • Recruiting
        • Research Site
      • Marbella (Málaga), Spain, 29603
        • Recruiting
        • Research Site
      • Mataró, Spain, 08302
        • Withdrawn
        • Research Site
      • Mataró, Spain, 08303
        • Recruiting
        • Research Site
      • Málaga, Spain, 29010
        • Recruiting
        • Research Site
      • Palma, Spain, 07011
        • Recruiting
        • Research Site
      • Patraix, Spain, 46017
        • Recruiting
        • Research Site
      • Santa Cruz de Tenerife, Spain, 38010
        • Withdrawn
        • Research Site
      • Santiago de Compostela-Coruña, Spain, 15706
        • Recruiting
        • Research Site
      • Gothenburg, Sweden, 41345
        • Recruiting
        • Research Site
      • Gothenburg, Sweden, 413 46
        • Withdrawn
        • Research Site
      • Höllviken, Sweden, 236 51
        • Recruiting
        • Research Site
      • Kungsbacka, Sweden, 43480
        • Recruiting
        • Research Site
      • Lund, Sweden, 22242
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 171 76
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 18288
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 117 27
        • Recruiting
        • Research Site
      • Stockholm, Sweden, 11883
        • Recruiting
        • Research Site
      • Umeå, Sweden, 901 85
        • Recruiting
        • Research Site
      • Uppsala, Sweden, 752 33
        • Recruiting
        • Research Site
      • Örebro, Sweden, 70185
        • Recruiting
        • Research Site
      • Changhua County, Taiwan, 500
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, 82445
        • Recruiting
        • Research Site
      • Kaohsiung City, Taiwan, TAIWAN
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40705
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 404
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 40201
        • Recruiting
        • Research Site
      • Taichung, Taiwan, 433004
        • Recruiting
        • Research Site
      • Tainan, Taiwan, 70403
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10002
        • Recruiting
        • Research Site
      • Taipei, Taiwan, 10449
        • Terminated
        • Research Site
      • Taoyuan, Taiwan, 00333
        • Recruiting
        • Research Site
      • Taoyuan City, Taiwan, 330
        • Recruiting
        • Research Site
      • Yunlin, Taiwan, 640
        • Recruiting
        • Research Site
      • Bang Kra So, Thailand, 11000
        • Recruiting
        • Research Site
      • Bangkok, Thailand, 10700
        • Recruiting
        • Research Site
      • Hat Yai, Thailand, 90110
        • Recruiting
        • Research Site
      • Khlong Luang, Thailand, 12120
        • Recruiting
        • Research Site
      • Muang, Thailand, 22000
        • Recruiting
        • Research Site
      • Muang, Thailand, 50200
        • Recruiting
        • Research Site
      • Muang, Thailand, 40002
        • Recruiting
        • Research Site
      • Ongkharak, Thailand, 26120
        • Recruiting
        • Research Site
      • Phitsanulok, Thailand, 65000
        • Recruiting
        • Research Site
      • Ratchathewi, Thailand, 10400
        • Recruiting
        • Research Site
      • Adana, Turkey (Türkiye), 01060
        • Recruiting
        • Research Site
      • Adana, Turkey (Türkiye), 01330
        • Recruiting
        • Research Site
      • Afyonkarahisar, Turkey (Türkiye), 03030
        • Recruiting
        • Research Site
      • Antalya, Turkey (Türkiye), 07059
        • Recruiting
        • Research Site
      • Bursa, Turkey (Türkiye), 16059
        • Recruiting
        • Research Site
      • Bursa, Turkey (Türkiye), 16110
        • Recruiting
        • Research Site
      • Isparta, Turkey (Türkiye), 32260
        • Withdrawn
        • Research Site
      • Istanbul, Turkey (Türkiye), 34844
        • Recruiting
        • Research Site
      • Istanbul, Turkey (Türkiye), 34785
        • Withdrawn
        • Research Site
      • Izmir, Turkey (Türkiye), 35965
        • Recruiting
        • Research Site
      • Izmir, Turkey (Türkiye), 35330
        • Recruiting
        • Research Site
      • Kayseri, Turkey (Türkiye), 38030
        • Recruiting
        • Research Site
      • Kocaeli, Turkey (Türkiye), 41380
        • Recruiting
        • Research Site
      • Mersin, Turkey (Türkiye), 33343
        • Recruiting
        • Research Site
      • Tekirdağ, Turkey (Türkiye), 59030
        • Recruiting
        • Research Site
      • Zeytinburnu, Turkey (Türkiye), 34020
        • Recruiting
        • Research Site
      • Çanakkale, Turkey (Türkiye), 17110
        • Recruiting
        • Research Site
      • Çankaya, Turkey (Türkiye), 06700
        • Recruiting
        • Research Site
      • Chernivtsi, Ukraine, 58029
        • Recruiting
        • Research Site
      • Chernivtsі, Ukraine, 58002
        • Recruiting
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76018
        • Recruiting
        • Research Site
      • Ivano-Frankivsk, Ukraine, 76019
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 02081
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 03037
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 03680
        • Recruiting
        • Research Site
      • Kyiv, Ukraine, 02002
        • Recruiting
        • Research Site
      • Lviv, Ukraine, 79016
        • Recruiting
        • Research Site
      • Ternopil, Ukraine, 46001
        • Recruiting
        • Research Site
      • Uzhhorod, Ukraine, 88018
        • Recruiting
        • Research Site
      • Uzhhorod, Ukraine, 88002
        • Recruiting
        • Research Site
      • Vinnytsia, Ukraine, 21009
        • Withdrawn
        • Research Site
      • Vinnytsia, Ukraine, 21001
        • Recruiting
        • Research Site
      • Vinnytsia, Ukraine, 21029
        • Recruiting
        • Research Site
      • Bicester, United Kingdom, OX26 6AT
        • Recruiting
        • Research Site
      • Bollington, United Kingdom, SK10 5JH
        • Recruiting
        • Research Site
      • Bradford, United Kingdom, BD13 2GD
        • Recruiting
        • Research Site
      • Cardiff, United Kingdom, CF37 2DR
        • Recruiting
        • Research Site
      • Chesterfield, United Kingdom, S40 4AA
        • Recruiting
        • Research Site
      • Corby, United Kingdom, NN17 2UR
        • Recruiting
        • Research Site
      • Cottingham, United Kingdom, HU16 5JQ
        • Withdrawn
        • Research Site
      • Fowey, United Kingdom, PL23 1DT
        • Recruiting
        • Research Site
      • Glasgow, United Kingdom, G4 0SF
        • Recruiting
        • Research Site
      • Hounslow, United Kingdom, TW4 7NR
        • Recruiting
        • Research Site
      • Liverpool, United Kingdom, L14 3PE
        • Recruiting
        • Research Site
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • Research Site
      • London, United Kingdom, SW1P 2PF
        • Recruiting
        • Research Site
      • London, United Kingdom, EC1M 6BQ
        • Completed
        • Research Site
      • Manchester, United Kingdom, M8 5RB
        • Recruiting
        • Research Site
      • Newquay, United Kingdom, TR7 1RU
        • Recruiting
        • Research Site
      • North Somerset, United Kingdom, BS23 3HQ
        • Recruiting
        • Research Site
      • Northallerton, United Kingdom, DL7 8AW
        • Recruiting
        • Research Site
      • Norwich, United Kingdom, NR1 1RB
        • Withdrawn
        • Research Site
      • Nottingham, United Kingdom, NG9 6DX
        • Withdrawn
        • Research Site
      • Perth, United Kingdom, PH1 1NX
        • Withdrawn
        • Research Site
      • Poole, United Kingdom, BH16 5PW
        • Recruiting
        • Research Site
      • Sheffield, United Kingdom, S7 1NF
        • Recruiting
        • Research Site
      • Torbay, United Kingdom, TQ1 4QX
        • Recruiting
        • Research Site
      • Whitney, United Kingdom, OX29 4QB
        • Recruiting
        • Research Site
      • Witney, United Kingdom, OX28 6JS
        • Recruiting
        • Research Site
    • Alabama
      • Athens, Alabama, United States, 35611
        • Terminated
        • Research Site
      • Cullman, Alabama, United States, 35058
        • Recruiting
        • Research Site
      • Fairhope, Alabama, United States, 36532
        • Terminated
        • Research Site
      • Huntsville, Alabama, United States, 35801
        • Terminated
        • Research Site
      • Mobile, Alabama, United States, 36608
        • Recruiting
        • Research Site
      • Sheffield, Alabama, United States, 35660
        • Withdrawn
        • Research Site
    • Arizona
      • Gilbert, Arizona, United States, 85296
        • Recruiting
        • Research Site
      • Glendale, Arizona, United States, 85308
        • Withdrawn
        • Research Site
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Research Site
      • Mesa, Arizona, United States, 85213
        • Recruiting
        • Research Site
      • Phoenix, Arizona, United States, 85006
        • Terminated
        • Research Site
      • Tempe, Arizona, United States, 85283
        • Terminated
        • Research Site
      • Tempe, Arizona, United States, 85281
        • Suspended
        • Research Site
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Research Site
      • Tucson, Arizona, United States, 85710
        • Recruiting
        • Research Site
    • California
      • Apple Valley, California, United States, 92307
        • Withdrawn
        • Research Site
      • Canoga Park, California, United States, 91303
        • Suspended
        • Research Site
      • Castroville, California, United States, 95012
        • Recruiting
        • Research Site
      • Garden Grove, California, United States, 92844
        • Recruiting
        • Research Site
      • Gardena, California, United States, 90247
        • Terminated
        • Research Site
      • Inglewood, California, United States, 90301
        • Recruiting
        • Research Site
      • La Mesa, California, United States, 91942
        • Recruiting
        • Research Site
      • La Palma, California, United States, 90623
        • Recruiting
        • Research Site
      • Lomita, California, United States, 90717
        • Recruiting
        • Research Site
      • Long Beach, California, United States, 90815
        • Recruiting
        • Research Site
      • Los Alamitos, California, United States, 90720
        • Terminated
        • Research Site
      • Mission Viejo, California, United States, 92691
        • Recruiting
        • Research Site
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Research Site
      • North Hollywood, California, United States, 91602
        • Terminated
        • Research Site
      • Pomona, California, United States, 91768
        • Recruiting
        • Research Site
      • Sacramento, California, United States, 95823
        • Recruiting
        • Research Site
      • Sacramento, California, United States, 95831
        • Recruiting
        • Research Site
      • San Bernardino, California, United States, 92408
        • Terminated
        • Research Site
      • San Diego, California, United States, 92111
        • Terminated
        • Research Site
      • San Dimas, California, United States, 91773
        • Withdrawn
        • Research Site
      • Santa Ana, California, United States, 92704
        • Withdrawn
        • Research Site
      • Tarzana, California, United States, 91356
        • Recruiting
        • Research Site
      • Thousand Oaks, California, United States, 91360
        • Recruiting
        • Research Site
      • Van Nuys, California, United States, 91405
        • Withdrawn
        • Research Site
      • Vista, California, United States, 92081
        • Recruiting
        • Research Site
      • Westminster, California, United States, 92683
        • Suspended
        • Research Site
    • Colorado
      • Aurora, Colorado, United States, 80012
        • Recruiting
        • Research Site
      • Denver, Colorado, United States, 80228
        • Recruiting
        • Research Site
      • Englewood, Colorado, United States, 80110
        • Terminated
        • Research Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Terminated
        • Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33435
        • Recruiting
        • Research Site
      • Bradenton, Florida, United States, 34209
        • Recruiting
        • Research Site
      • Cape Coral, Florida, United States, 33990
        • Recruiting
        • Research Site
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Research Site
      • Clearwater, Florida, United States, 33756
        • Recruiting
        • Research Site
      • Crystal River, Florida, United States, 34429
        • Recruiting
        • Research Site
      • Cutler Bay, Florida, United States, 33189
        • Recruiting
        • Research Site
      • Edgewater, Florida, United States, 32132
        • Recruiting
        • Research Site
      • Fort Lauderdale, Florida, United States, 33308
        • Recruiting
        • Research Site
      • Fort Myers, Florida, United States, 33912
        • Terminated
        • Research Site
      • Hialeah, Florida, United States, 33012
        • Terminated
        • Research Site
      • Hialeah, Florida, United States, 33013
        • Terminated
        • Research Site
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Research Site
      • Homestead, Florida, United States, 33033
        • Recruiting
        • Research Site
      • Kissimmee, Florida, United States, 34746
        • Recruiting
        • Research Site
      • Kissimmee, Florida, United States, 34741
        • Withdrawn
        • Research Site
      • Lake City, Florida, United States, 32055
        • Recruiting
        • Research Site
      • Lake City, Florida, United States, 32055
        • Terminated
        • Research Site
      • Lake Worth, Florida, United States, 33467
        • Recruiting
        • Research Site
      • Lakeland, Florida, United States, 33813
        • Recruiting
        • Research Site
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Research Site
      • Loxahatchee Groves, Florida, United States, 33470
        • Withdrawn
        • Research Site
      • Miami, Florida, United States, 33175
        • Recruiting
        • Research Site
      • Miami, Florida, United States, 33175
        • Terminated
        • Research Site
      • Miami, Florida, United States, 33155
        • Recruiting
        • Research Site
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Research Site
      • Naples, Florida, United States, 34102
        • Recruiting
        • Research Site
      • Ocala, Florida, United States, 34470
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32807
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32819
        • Recruiting
        • Research Site
      • Orlando, Florida, United States, 32825
        • Recruiting
        • Research Site
      • Ormond Beach, Florida, United States, 32174
        • Recruiting
        • Research Site
      • Pembroke Pines, Florida, United States, 33024
        • Recruiting
        • Research Site
      • Plantation, Florida, United States, 33324
        • Recruiting
        • Research Site
      • St. Petersburg, Florida, United States, 33713
        • Recruiting
        • Research Site
      • Sun City Center, Florida, United States, 33573
        • Terminated
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • Research Site
      • Tamarac, Florida, United States, 33321
        • Suspended
        • Research Site
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Research Site
      • Tampa, Florida, United States, 33606
        • Recruiting
        • Research Site
      • Tampa, Florida, United States, 33625
        • Terminated
        • Research Site
    • Georgia
      • Fayetteville, Georgia, United States, 30214
        • Terminated
        • Research Site
      • Peachtree Corners, Georgia, United States, 30092
        • Withdrawn
        • Research Site
      • Savannah, Georgia, United States, 31406
        • Recruiting
        • Research Site
      • Tucker, Georgia, United States, 30084
        • Recruiting
        • Research Site
    • Idaho
      • Boise, Idaho, United States, 83706
        • Terminated
        • Research Site
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Research Site
      • Winfield, Illinois, United States, 60190
        • Recruiting
        • Research Site
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Recruiting
        • Research Site
    • Iowa
      • Sioux City, Iowa, United States, 51106
        • Recruiting
        • Research Site
    • Kansas
      • Newton, Kansas, United States, 67114
        • Terminated
        • Research Site
      • Wichita, Kansas, United States, 67218
        • Recruiting
        • Research Site
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • Research Site
      • Paducah, Kentucky, United States, 42001
        • Terminated
        • Research Site
    • Louisiana
      • Lafayette, Louisiana, United States, 70508
        • Recruiting
        • Research Site
      • Monroe, Louisiana, United States, 71201
        • Recruiting
        • Research Site
      • Shreveport, Louisiana, United States, 71105
        • Recruiting
        • Research Site
      • Zachary, Louisiana, United States, 70791
        • Recruiting
        • Research Site
    • Maryland
      • Glen Burnie, Maryland, United States, 21061
        • Withdrawn
        • Research Site
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • Research Site
      • Potomac, Maryland, United States, 20854
        • Terminated
        • Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Research Site
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • Research Site
      • Flint, Michigan, United States, 48504
        • Recruiting
        • Research Site
      • Southfield, Michigan, United States, 48075
        • Recruiting
        • Research Site
      • Southfield, Michigan, United States, 48034
        • Recruiting
        • Research Site
    • Mississippi
      • Gulfport, Mississippi, United States, 39503
        • Recruiting
        • Research Site
      • Olive Branch, Mississippi, United States, 38654
        • Recruiting
        • Research Site
    • Missouri
      • Kansas City, Missouri, United States, 64116
        • Suspended
        • Research Site
      • Liberty, Missouri, United States, 64068
        • Withdrawn
        • Research Site
      • St Louis, Missouri, United States, 63104
        • Recruiting
        • Research Site
      • St Louis, Missouri, United States, 63136
        • Terminated
        • Research Site
    • Montana
      • Missoula, Montana, United States, 59808
        • Recruiting
        • Research Site
    • Nebraska
      • Fremont, Nebraska, United States, 68025
        • Recruiting
        • Research Site
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • Research Site
      • Lincoln, Nebraska, United States, 68510
        • Withdrawn
        • Research Site
      • Omaha, Nebraska, United States, 68134
        • Terminated
        • Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89101
        • Recruiting
        • Research Site
      • Las Vegas, Nevada, United States, 89102
        • Terminated
        • Research Site
      • Las Vegas, Nevada, United States, 89119
        • Terminated
        • Research Site
      • Las Vegas, Nevada, United States, 89121
        • Recruiting
        • Research Site
    • New Jersey
      • Lawrence, New Jersey, United States, 08648
        • Withdrawn
        • Research Site
      • Mullica Hill, New Jersey, United States, 08062
        • Recruiting
        • Research Site
      • Toms River, New Jersey, United States, 08755
        • Recruiting
        • Research Site
      • Union City, New Jersey, United States, 07087
        • Withdrawn
        • Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • Withdrawn
        • Research Site
    • New York
      • Albany, New York, United States, 12205
        • Recruiting
        • Research Site
      • Albany, New York, United States, 12208
        • Withdrawn
        • Research Site
      • Bronxville, New York, United States, 10708
        • Withdrawn
        • Research Site
      • Brooklyn, New York, United States, 11220
        • Terminated
        • Research Site
      • Massapequa, New York, United States, 11758
        • Recruiting
        • Research Site
      • New Windsor, New York, United States, 12553
        • Recruiting
        • Research Site
      • New York, New York, United States, 10036
        • Recruiting
        • Research Site
      • New York, New York, United States, 10065
        • Recruiting
        • Research Site
      • The Bronx, New York, United States, 10455
        • Recruiting
        • Research Site
      • Vestal, New York, United States, 13850
        • Terminated
        • Research Site
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Terminated
        • Research Site
      • Greensboro, North Carolina, United States, 27405
        • Recruiting
        • Research Site
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Research Site
      • Huntersville, North Carolina, United States, 28078
        • Recruiting
        • Research Site
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Research Site
      • Raleigh, North Carolina, United States, 27612
        • Suspended
        • Research Site
      • Salisbury, North Carolina, United States, 28144
        • Terminated
        • Research Site
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Research Site
      • Statesville, North Carolina, United States, 28677
        • Withdrawn
        • Research Site
      • Wilmington, North Carolina, United States, 28412
        • Terminated
        • Research Site
      • Winston-Salem, North Carolina, United States, 27104
        • Recruiting
        • Research Site
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Terminated
        • Research Site
      • Blue Ash, Ohio, United States, 45242
        • Recruiting
        • Research Site
      • Cleveland, Ohio, United States, 44130
        • Terminated
        • Research Site
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Research Site
      • Columbus, Ohio, United States, 43235
        • Terminated
        • Research Site
      • Marion, Ohio, United States, 43302
        • Recruiting
        • Research Site
      • Toledo, Ohio, United States, 43617
        • Withdrawn
        • Research Site
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Recruiting
        • Research Site
      • Oklahoma City, Oklahoma, United States, 73134
        • Recruiting
        • Research Site
      • Tulsa, Oklahoma, United States, 74133
        • Recruiting
        • Research Site
    • Oregon
      • Grants Pass, Oregon, United States, 97527
        • Terminated
        • Research Site
      • Medford, Oregon, United States, 97504
        • Recruiting
        • Research Site
      • Roseburg, Oregon, United States, 97471
        • Withdrawn
        • Research Site
    • Pennsylvania
      • Camp Hill, Pennsylvania, United States, 17011
        • Recruiting
        • Research Site
      • DuBois, Pennsylvania, United States, 15801
        • Withdrawn
        • Research Site
      • Exton, Pennsylvania, United States, 19341
        • Withdrawn
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Research Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Research Site
    • South Carolina
      • Anderson, South Carolina, United States, 29621
        • Recruiting
        • Research Site
      • Charleston, South Carolina, United States, 29414
        • Recruiting
        • Research Site
      • Charleston, South Carolina, United States, 29414
        • Terminated
        • Research Site
      • Columbia, South Carolina, United States, 29201
        • Withdrawn
        • Research Site
      • Gaffney, South Carolina, United States, 29340
        • Recruiting
        • Research Site
      • Spartanburg, South Carolina, United States, 29303
        • Recruiting
        • Research Site
      • Union, South Carolina, United States, 29379
        • Recruiting
        • Research Site
    • South Dakota
      • Pierre, South Dakota, United States, 57501
        • Withdrawn
        • Research Site
      • Rapid City, South Dakota, United States, 57701
        • Recruiting
        • Research Site
      • Sioux Falls, South Dakota, United States, 57104
        • Recruiting
        • Research Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Recruiting
        • Research Site
      • Elizabethton, Tennessee, United States, 37643
        • Terminated
        • Research Site
      • Franklin, Tennessee, United States, 37067
        • Recruiting
        • Research Site
      • Morristown, Tennessee, United States, 37813
        • Terminated
        • Research Site
      • Tullahoma, Tennessee, United States, 37388
        • Recruiting
        • Research Site
    • Texas
      • Abilene, Texas, United States, 79606
        • Recruiting
        • Research Site
      • Amarillo, Texas, United States, 79106
        • Withdrawn
        • Research Site
      • Austin, Texas, United States, 78704
        • Terminated
        • Research Site
      • Brownsville, Texas, United States, 78520
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75254
        • Recruiting
        • Research Site
      • Dallas, Texas, United States, 75235
        • Terminated
        • Research Site
      • Dallas, Texas, United States, 75225
        • Terminated
        • Research Site
      • El Paso, Texas, United States, 79902
        • Recruiting
        • Research Site
      • El Paso, Texas, United States, 79902
        • Terminated
        • Research Site
      • Forney, Texas, United States, 75126
        • Recruiting
        • Research Site
      • Georgetown, Texas, United States, 78633
        • Terminated
        • Research Site
      • Houston, Texas, United States, 77074
        • Withdrawn
        • Research Site
      • Houston, Texas, United States, 77089
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77079
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77002
        • Recruiting
        • Research Site
      • Houston, Texas, United States, 77008
        • Terminated
        • Research Site
      • Houston, Texas, United States, 77025
        • Terminated
        • Research Site
      • Houston, Texas, United States, 77207
        • Terminated
        • Research Site
      • Houston, Texas, United States, 77084
        • Terminated
        • Research Site
      • Houston, Texas, United States, 77024
        • Terminated
        • Research Site
      • Katy, Texas, United States, 77493
        • Withdrawn
        • Research Site
      • Katy, Texas, United States, 77450
        • Withdrawn
        • Research Site
      • Kerrville, Texas, United States, 78028
        • Terminated
        • Research Site
      • Kingwood, Texas, United States, 77339
        • Recruiting
        • Research Site
      • Lewisville, Texas, United States, 75057
        • Suspended
        • Research Site
      • McAllen, Texas, United States, 78504
        • Recruiting
        • Research Site
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Research Site
      • Paris, Texas, United States, 75462
        • Recruiting
        • Research Site
      • Plano, Texas, United States, 75093
        • Recruiting
        • Research Site
      • Plano, Texas, United States, 75024
        • Terminated
        • Research Site
      • Victoria, Texas, United States, 77901
        • Terminated
        • Research Site
      • Waco, Texas, United States, 76708
        • Recruiting
        • Research Site
      • Wichita Falls, Texas, United States, 76308
        • Terminated
        • Research Site
      • Wylie, Texas, United States, 75098
        • Recruiting
        • Research Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Withdrawn
        • Research Site
      • Ogden, Utah, United States, 84405
        • Recruiting
        • Research Site
      • Salt Lake City, Utah, United States, 84107
        • Terminated
        • Research Site
      • West Jordan, Utah, United States, 84088
        • Terminated
        • Research Site
      • West Valley City, Utah, United States, 84120
        • Recruiting
        • Research Site
    • Virginia
      • Newport News, Virginia, United States, 23606
        • Terminated
        • Research Site
      • Norfolk, Virginia, United States, 23504
        • Recruiting
        • Research Site
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • Research Site
      • Richmond, Virginia, United States, 23226
        • Terminated
        • Research Site
      • Suffolk, Virginia, United States, 23435
        • Recruiting
        • Research Site
    • Washington
      • Spokane, Washington, United States, 99218
        • Recruiting
        • Research Site
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Terminated
        • Research Site
    • Wisconsin
      • Cudahy, Wisconsin, United States, 53110
        • Recruiting
        • Research Site
      • Milwaukee, Wisconsin, United States, 53228
        • Recruiting
        • Research Site
      • Milwaukee, Wisconsin, United States, 53295
        • Terminated
        • Research Site

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Male or female participants must be 40 to 80 years of age inclusive, at the time of signing

    the ICF.

  2. Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
  3. A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%

    at V1.

  4. Current or former smokers with a history of at least 10 pack-years of cigarette smoking;

    defined as (number of cigarettes per day/20) x number of years smoked. Previous smokers are defined as those who have stopped smoking for at least 6

    months prior to V1.

  5. A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by

    the central laboratory

  6. A CAT score of ≥ 10 at Visit 1.
  7. Participant must fulfill at least 1 of the 4 CV disease/risk factor criteria below [(a), (b),

    (c), or (d)]:

    1. : Established CV Disease
    2. : Combination of CV risk factors:

      • Hypertension
      • Diabetes Mellitus
      • Chronic Kidney Disease
      • Dyslipidemia
      • Obesity
    3. : High risk of CV disease determined using an established CV risk assessment

      tool.

    4. : CT coronary Artery Calcification
  8. Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as

    required by the protocol.

  9. Willing to visit at the study site or participate in virtual visits as required per the protocol

    to complete all study assessments.

  10. A female is eligible to enter and participate in the study if the female is of:

    • Non-childbearing potential: either permanently sterilized or who are post-menopausal.
    • Childbearing potential: has a negative serum pregnancy test at V1 and must use one

    highly effective form of birth control.

  11. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

  1. Active diagnosis of asthma within the past 5 years (previous diagnosis as a child or adolescent are eligible), asthma-COPD overlap, or any other chronic respiratory disease other than COPD such as alpha-1 antitrypsin deficiency, active tuberculosis, lung fibrosis, sarcoidosis, interstitial lung disease, and pulmonary hypertension.
  2. End-stage renal disease requiring renal replacement therapy
  3. History of heart or lung transplant or actively listed for heart or lung transplant.
  4. Implanted left ventricular assist device or implant anticipated in < 3 months.
  5. History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
  6. Unstable or life-threatening cardiac disease - participants with any of the following at Visit 1 would be excluded:

    1. An MI or unstable angina in the last 8 weeks
    2. Unstable or life-threatening cardiac arrhythmia requiring intervention in the last 8 weeks.

    NOTE: Any participant who experiences unstable or life-threatening cardiac disease during the run-in period will be excluded but can be rescreened 8 weeks after the resolution of the event.

  7. Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
  8. Any life-threatening condition, including malignancy, with a life expectancy < 5 years, other than CV disease or COPD, that might prevent the participant from completing the study.
  9. Use of maintenance ICS treatment within the past 12 months.
  10. Unable to abstain from protocol-defined prohibited medications
  11. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer prior to Visit 1 (any other investigational product that is not identified in protocol is prohibited for use during the duration of the study).
  12. Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
  13. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
  14. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  15. Previous randomization in the present study.
  16. For females only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding

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: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BGF arm
BGF MDI 320/14.4/9.6 μg BID
Budesonide, glycopyrronium, and formoterol fumarate pressurized inhalation suspension
Experimental: GFF arm
GFF MDI 14.4/9.6 μg BID
Glycopyrronium and formoterol fumarate pressurized inhalation suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first severe cardiac or COPD event
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary outcomes.
Up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to first severe COPD exacerbation event
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe COPD exacerbations.
Up to 3 years
Time to first severe cardiac event
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on severe cardiac outcomes.
Up to 3 years
Time to cardiopulmonary death
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on cardiopulmonary deaths.
Up to 3 years
Time to Myocardial Infarction (MI) hospitalization or cardiac death
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to MI hospitalization (or cardiac death).
Up to 3 years
Time to Heart Failure (HF) acute healthcare visit/hospitalization or cardiac death
Time Frame: Up to 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on the time to HF acute healthcare visit/hospitalization (or cardiac death).
Up to 3 years
Moderate/severe COPD exacerbation rate
Time Frame: Over time, up 3 years
Evaluate the effect of combination triple therapy (BGF MDI 320/14.4/9.6 μg) compared with dual bronchodilator therapy (GFF MDI 14.4/9.6 μg) on moderate/severe COPD exacerbations.
Over time, up 3 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Serious Adverse Events (SAEs) and Adverse Events leading to discontinuation (DAEs), Adverse Events of Special Interest (AESIs) of pneumonia leading to hospitalization or death
Time Frame: Up to 3 years
To assess the safety and tolerability of BGF MDI and GFF MDI
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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)

February 21, 2024

Primary Completion (Estimated)

December 3, 2027

Study Completion (Estimated)

December 3, 2027

Study Registration Dates

First Submitted

February 21, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Actual)

February 28, 2024

Study Record Updates

Last Update Posted (Actual)

May 13, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

IPD Sharing Time Frame

AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:

https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Access Criteria

When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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