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

March 11, 2024 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

Status

Recruiting

Conditions

COPD (Chronic Obstructive Pulmonary Disease)

Intervention / Treatment

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

Name: AstraZeneca Clinical Study Information Center
Phone Number: 1-877-240-9479
Email: information.center@astrazeneca.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1414AIF
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1425BEN
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1425AGC
    - Not yet recruiting
    - Research Site
  - Buenos Aires, Argentina, C1012AAR
    - Not yet recruiting
    - Research Site
  - Caba, Argentina, C1061
    - Not yet recruiting
    - Research Site
  - Capital Federal, Argentina, C1060ABN
    - Not yet recruiting
    - Research Site
  - Ciudad Autónomas De Buenos Aires, Argentina, 1425
    - Not yet recruiting
    - Research Site
  - Florencio Varela, Argentina, 1888
    - Not yet recruiting
    - Research Site
  - Florida, Argentina, B1602DQD
    - Not yet recruiting
    - Research Site
  - Mar del Plata, Argentina, B7600GWV
    - Not yet recruiting
    - Research Site
  - Mendoza, Argentina, M5500GIP
    - Not yet recruiting
    - Research Site
  - Ranelagh, Argentina, 1886
    - Not yet recruiting
    - Research Site
  - Rosario, Argentina, 2000
    - Not yet recruiting
    - Research Site
  - San Fernando, Argentina, B1646EBJ
    - Not yet recruiting
    - Research Site
  - San Miguel de Tucumán, Argentina, T4000CBC
    - Not yet recruiting
    - Research Site
Australia
- - Cairns, Australia, 4870
    - Not yet recruiting
    - Research Site
  - Spearwood, Australia, 6163
    - Not yet recruiting
    - Research Site
Austria
- - Bad Ischl, Austria, 4820
    - Not yet recruiting
    - Research Site
  - Braunau, Austria, 5280
    - Not yet recruiting
    - Research Site
  - Feldbach, Austria, 8330
    - Not yet recruiting
    - Research Site
  - Wien, Austria, 1090
    - Not yet recruiting
    - Research Site
Brazil
- - Belo Horizonte, Brazil, 30150-221
    - Not yet recruiting
    - Research Site
  - Belo Horizonte, Brazil, 30110-934
    - Not yet recruiting
    - Research Site
  - Belo Horizonte, Brazil, 30220-140
    - Not yet recruiting
    - Research Site
  - Blumenau, Brazil, 89030-101
    - Not yet recruiting
    - Research Site
  - Brasilia, Brazil, 71681-603
    - Not yet recruiting
    - Research Site
  - Brasilia, Brazil, 70390-700
    - Not yet recruiting
    - Research Site
  - Brasilia, Brazil, 70200-730
    - Not yet recruiting
    - Research Site
  - Brasilia, Brazil, 70712-903
    - Not yet recruiting
    - Research Site
  - Campina Grande do Sul, Brazil, 83.430-000
    - Not yet recruiting
    - Research Site
  - Campinas, Brazil, 13060-080
    - Not yet recruiting
    - Research Site
  - Caxias do Sul, Brazil, 95070-560
    - Not yet recruiting
    - Research Site
  - Curitiba, Brazil, 80030-110
    - Not yet recruiting
    - Research Site
  - Ijui, Brazil, 98700-000
    - Not yet recruiting
    - Research Site
  - Juiz de Fora, Brazil, 36033-318
    - Not yet recruiting
    - Research Site
  - Natal, Brazil, 59020-035
    - Not yet recruiting
    - Research Site
  - Niterói, Brazil, 24020-096
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035-903
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 90035074
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 9061-000
    - Not yet recruiting
    - Research Site
  - Porto Alegre, Brazil, 91350-280
    - Not yet recruiting
    - Research Site
  - Recife, Brazil, 50740-465
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 22281-100
    - Not yet recruiting
    - Research Site
  - Rio de Janeiro, Brazil, 20551-030
    - Not yet recruiting
    - Research Site
  - Salvador, Brazil, 40170-130
    - Not yet recruiting
    - Research Site
  - Santo Andre, Brazil, 09080-110
    - Not yet recruiting
    - Research Site
  - Sao Bernardo do Campo, Brazil, 09750-420
    - Not yet recruiting
    - Research Site
  - Sao Jose Do Rio Preto, Brazil, 15090-000
    - Not yet recruiting
    - Research Site
  - Serra, Brazil, 29160-750
    - Not yet recruiting
    - Research Site
  - Sorocaba, Brazil, 18040-425
    - Not yet recruiting
    - Research Site
  - São Paulo, Brazil, 04012-180
    - Not yet recruiting
    - Research Site
  - Volta Redonda, Brazil, 27258-000
    - Not yet recruiting
    - Research Site
  - Votuporanga, Brazil, 15501-405
    - Not yet recruiting
    - Research Site
Bulgaria
- - Burgas, Bulgaria, 8000
    - Not yet recruiting
    - Research Site
  - Dupnitsa, Bulgaria, 2600
    - Not yet recruiting
    - Research Site
  - Haskovo, Bulgaria, 6300
    - Not yet recruiting
    - Research Site
  - Kozloduy, Bulgaria, 3320
    - Not yet recruiting
    - Research Site
  - Montana, Bulgaria, 3400
    - Not yet recruiting
    - Research Site
  - Panagyurishte, Bulgaria, 4500
    - Not yet recruiting
    - Research Site
  - Pazardzhik, Bulgaria, 4400
    - Not yet recruiting
    - Research Site
  - Pleven, Bulgaria, 5800
    - Not yet recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4004
    - Not yet recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4000
    - Not yet recruiting
    - Research Site
  - Plovdiv, Bulgaria, 4003
    - Not yet recruiting
    - Research Site
  - Ruse, Bulgaria, 7002
    - Not yet recruiting
    - Research Site
  - Sandanski, Bulgaria, 2800
    - Not yet recruiting
    - Research Site
  - Sliven, Bulgaria, 8800
    - Not yet recruiting
    - Research Site
  - Sofia, Bulgaria, 1000
    - Not yet recruiting
    - Research Site
  - Vratsa, Bulgaria, 3000
    - Not yet recruiting
    - Research Site
  - Yambol, Bulgaria, 8600
    - Not yet recruiting
    - Research Site
Canada
- - Quebec, Canada, G1G 3Y8
    - Recruiting
    - Research Site
  - Quebec, Canada, G1V 4G5
    - Not yet recruiting
    - Research Site
  - Quebec, Canada, G3K 2P8
    - Not yet recruiting
    - Research Site
  - Quebec, Canada, G1W 4R4
    - Not yet recruiting
    - Research Site
- Alberta
  - Sherwood Park, Alberta, Canada, T8L 0N2
    - Not yet recruiting
    - Research Site
- British Columbia
  - Kelowna, British Columbia, Canada, V1Y 2H4
    - Not yet recruiting
    - Research Site
- Nova Scotia
  - Sydney, Nova Scotia, Canada, B1M 0A1
    - Not yet recruiting
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Recruiting
    - Research Site
  - Guelph, Ontario, Canada, N1H 1B1
    - Not yet recruiting
    - Research Site
  - Hamilton, Ontario, Canada, L8M 1K7
    - Recruiting
    - Research Site
  - Thunder Bay, Ontario, Canada, P7B 5N3
    - Not yet recruiting
    - Research Site
  - Toronto, Ontario, Canada, M5T 3A9
    - Not yet recruiting
    - Research Site
- Quebec
  - St Charles Borromee, Quebec, Canada, J6E 2B4
    - Not yet recruiting
    - Research Site
  - Trois-Rivières, Quebec, Canada, G8T 7A1
    - Recruiting
    - Research Site
  - Trois-Rivières, Quebec, Canada, G9A 4P3
    - Not yet recruiting
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Not yet recruiting
    - Research Site
Chile
- - Curico, Chile, 3341643
    - Not yet recruiting
    - Research Site
  - Quillota, Chile, 2260000
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7750495
    - Not yet recruiting
    - Research Site
  - Santiago, Chile, 7500691
    - Not yet recruiting
    - Research Site
  - Talca, Chile, 3465584
    - Not yet recruiting
    - Research Site
  - Temuco, Chile, 4810345
    - Not yet recruiting
    - Research Site
  - Victoria, Chile, 4720097
    - Not yet recruiting
    - Research Site
  - Vitacura, Chile, 7630226
    - Not yet recruiting
    - Research Site
  - Viña del Mar, Chile, 2540488
    - Not yet recruiting
    - Research Site
China
- - Anhui, China, 230061
    - Not yet recruiting
    - Research Site
  - Baotou, China, 14010
    - Not yet recruiting
    - Research Site
  - Baotou, China
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410004
    - Not yet recruiting
    - Research Site
  - Changsha, China, 410015
    - Not yet recruiting
    - Research Site
  - Changzhi, China, 46000
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610072
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 611130
    - Not yet recruiting
    - Research Site
  - Chengdu, China, 610031
    - Not yet recruiting
    - Research Site
  - Chifeng, China, 024000
    - Not yet recruiting
    - Research Site
  - Chongqing, China, 401320
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510000
    - Not yet recruiting
    - Research Site
  - Guangzhou, China, 510145
    - Not yet recruiting
    - Research Site
  - Hangzhou, China, 310006
    - Not yet recruiting
    - Research Site
  - Heze, China, 274099
    - Not yet recruiting
    - Research Site
  - Hohhot, China, 010017
    - Not yet recruiting
    - Research Site
  - Hohhot, China, 750306
    - Not yet recruiting
    - Research Site
  - Huizhou, China, 516002
    - Not yet recruiting
    - Research Site
  - Huizhou, China, 516001
    - Not yet recruiting
    - Research Site
  - Jinhua, China, 321099
    - Not yet recruiting
    - Research Site
  - Jining, China, 272029
    - Not yet recruiting
    - Research Site
  - Kaifeng, China, 475000
    - Not yet recruiting
    - Research Site
  - Nanchang, China, 330006
    - Not yet recruiting
    - Research Site
  - Nanjing, China, 210009
    - Not yet recruiting
    - Research Site
  - Pingxiang, China, 337055
    - Not yet recruiting
    - Research Site
  - Qingdao, China, 266011
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200433
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 201199
    - Not yet recruiting
    - Research Site
  - Shanghai, China, 200240
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110022
    - Not yet recruiting
    - Research Site
  - Shenyang, China, 110083
    - Not yet recruiting
    - Research Site
  - Shijiazhuang, China, 50051
    - Not yet recruiting
    - Research Site
  - Siping, China, 136000
    - Not yet recruiting
    - Research Site
  - Taicang, China, 215400
    - Not yet recruiting
    - Research Site
  - Taiyuan, China, 030001
    - Not yet recruiting
    - Research Site
  - Taiyuan, China, 030012
    - Not yet recruiting
    - Research Site
  - Taiyuan, China, 030032
    - Not yet recruiting
    - Research Site
  - Taizhou, China, 318000
    - Not yet recruiting
    - Research Site
  - Urumqi, China, 831118
    - Not yet recruiting
    - Research Site
  - Wenzhou, China, 325027
    - Not yet recruiting
    - Research Site
  - Xi'an, China, 710006
    - Not yet recruiting
    - Research Site
  - Xinxiang, China, 453002
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221000
    - Not yet recruiting
    - Research Site
  - Xuzhou, China, 221009
    - Not yet recruiting
    - Research Site
  - Yangzhou, China, 225001
    - Not yet recruiting
    - Research Site
  - Yangzhou, China, 225000
    - Not yet recruiting
    - Research Site
  - Yinchuan, China, 750004
    - Not yet recruiting
    - Research Site
  - Yinchuan, China, 750001
    - Not yet recruiting
    - Research Site
  - Zhengzhou, China, 450006
    - Not yet recruiting
    - Research Site
Colombia
- - Barranquilla, Colombia, 080020
    - Not yet recruiting
    - Research Site
  - Bogota, Colombia, 111411
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050025
    - Not yet recruiting
    - Research Site
  - Medellin, Colombia, 050030
    - Not yet recruiting
    - Research Site
  - Rionegro, Colombia, 054047
    - Not yet recruiting
    - Research Site
Czechia
- - Brandys nad Labem, Czechia, 250 01
    - Not yet recruiting
    - Research Site
  - Olomouc, Czechia, 772 00
    - Not yet recruiting
    - Research Site
  - Ostrava, Czechia, 702 00
    - Not yet recruiting
    - Research Site
  - Praha 1, Czechia, 110 00
    - Not yet recruiting
    - Research Site
  - Rokycany, Czechia, 337 22
    - Not yet recruiting
    - Research Site
Denmark
- - Aalborg, Denmark, 9000
    - Not yet recruiting
    - Research Site
  - Esbjerg, Denmark, 6700
    - Not yet recruiting
    - Research Site
  - Hvidovre, Denmark, 2650
    - Not yet recruiting
    - Research Site
  - København NV, Denmark, 2400
    - Not yet recruiting
    - Research Site
  - Næstved, Denmark, 4700
    - Not yet recruiting
    - Research Site
  - Vejle, Denmark, 7100
    - Not yet recruiting
    - Research Site
Finland
- - Helsinki, Finland, 00180
    - Not yet recruiting
    - Research Site
  - Helsinki, Finland, 00980
    - Not yet recruiting
    - Research Site
  - Kuopio, Finland, 70100
    - Not yet recruiting
    - Research Site
  - Turku, Finland, 20100
    - Not yet recruiting
    - Research Site
France
- - Aix en Provence, France, 13616
    - Not yet recruiting
    - Research Site
  - Aurillac Cedex, France, 15002
    - Not yet recruiting
    - Research Site
  - Bayonne, France, 64100
    - Not yet recruiting
    - Research Site
  - Biarritz, France, 64200
    - Not yet recruiting
    - Research Site
  - Brest, France, 29200
    - Not yet recruiting
    - Research Site
  - Brest Cedex, France, 29609
    - Not yet recruiting
    - Research Site
  - Cannes, France, 06414
    - Not yet recruiting
    - Research Site
  - La Tronche, France, 38700
    - Not yet recruiting
    - Research Site
  - Le Coudray Cedex, France, 28630
    - Not yet recruiting
    - Research Site
  - Lyon Cedex 04, France, 69317
    - Not yet recruiting
    - Research Site
  - Marseille, France, 13015
    - Not yet recruiting
    - Research Site
  - Marseille, France, 13003
    - Not yet recruiting
    - Research Site
  - Mulhouse, France, 68100
    - Not yet recruiting
    - Research Site
  - Paris, France, 75679
    - Not yet recruiting
    - Research Site
  - Paris Cedex 13, France, 75651
    - Not yet recruiting
    - Research Site
  - Pessac, France, 33604
    - Not yet recruiting
    - Research Site
  - Quint-Fonsegrives, France, 31130
    - Not yet recruiting
    - Research Site
  - Reims, France, 51092
    - Not yet recruiting
    - Research Site
  - Roscoff, France, 29680
    - Not yet recruiting
    - Research Site
  - VANNES cedex, France, 56017
    - Not yet recruiting
    - Research Site
  - Vandoeuvre-Les-Nancy Cedex, France, 54511
    - Not yet recruiting
    - Research Site
Germany
- - Augsburg, Germany, 86150
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 13187
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12157
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12203
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 10787
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12159
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 12627
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 10625
    - Not yet recruiting
    - Research Site
  - Berlin, Germany, 10969
    - Not yet recruiting
    - Research Site
  - Bremen, Germany, 28215
    - Not yet recruiting
    - Research Site
  - Bremen, Germany, 28259
    - Not yet recruiting
    - Research Site
  - Cottbus, Germany, 03050
    - Not yet recruiting
    - Research Site
  - Dachau, Germany, 85221
    - Not yet recruiting
    - Research Site
  - Darmstadt, Germany, 64283
    - Not yet recruiting
    - Research Site
  - Deggingen, Germany, 73326
    - Not yet recruiting
    - Research Site
  - Dresden, Germany, 01069
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45127
    - Not yet recruiting
    - Research Site
  - Essen, Germany, 45355
    - Not yet recruiting
    - Research Site
  - Frankfurt, Germany, 60596
    - Not yet recruiting
    - Research Site
  - Frankfurt/Main, Germany, 60389
    - Not yet recruiting
    - Research Site
  - Großhansdorf, Germany, 22927
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 22335
    - Not yet recruiting
    - Research Site
  - Hamburg, Germany, 22459
    - Not yet recruiting
    - Research Site
  - Hannover, Germany, 30449
    - Not yet recruiting
    - Research Site
  - Hannover, Germany, D-30173
    - Not yet recruiting
    - Research Site
  - Heidelberg, Germany, 69115
    - Not yet recruiting
    - Research Site
  - Ibbenbüren, Germany, 49477
    - Not yet recruiting
    - Research Site
  - Karlsruhe, Germany, 76137
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04103
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04299
    - Not yet recruiting
    - Research Site
  - Leipzig, Germany, 04157
    - Not yet recruiting
    - Research Site
  - Lübeck, Germany, 23552
    - Not yet recruiting
    - Research Site
  - Mainz, Germany, 55128
    - Not yet recruiting
    - Research Site
  - Moers, Germany, 47441
    - Not yet recruiting
    - Research Site
  - München, Germany, 80336
    - Not yet recruiting
    - Research Site
  - Offenbach am Main, Germany, 63069
    - Not yet recruiting
    - Research Site
  - Rheine, Germany, 48431
    - Not yet recruiting
    - Research Site
  - Riesa, Germany, 01587
    - Not yet recruiting
    - Research Site
  - Solingen, Germany, 42699
    - Not yet recruiting
    - Research Site
  - Wallerfing, Germany, 94574
    - Not yet recruiting
    - Research Site
  - Weißenburg, Germany, 91781
    - Not yet recruiting
    - Research Site
  - Wermsdorf, Germany, 04779
    - Not yet recruiting
    - Research Site
  - Wiesbaden, Germany, 65189
    - Not yet recruiting
    - Research Site
  - Witten, Germany, 58452
    - Not yet recruiting
    - Research Site
Greece
- - Athens, Greece, 11521
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 11527
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 12462
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 17562
    - Not yet recruiting
    - Research Site
  - Athens, Greece, 18547
    - Not yet recruiting
    - Research Site
  - Exohi Thessaloniki, Greece, 57010
    - Not yet recruiting
    - Research Site
  - Ioannina, Greece, 45500
    - Not yet recruiting
    - Research Site
  - Patras, Greece, 26500
    - Not yet recruiting
    - Research Site
  - Thessaloniki, Greece, 57010
    - Not yet recruiting
    - Research Site
Hungary
- - Budapest, Hungary, 1121
    - Not yet recruiting
    - Research Site
  - Budapest, Hungary, 1194
    - Not yet recruiting
    - Research Site
  - Edelény, Hungary, 3780
    - Not yet recruiting
    - Research Site
  - Gyöngyös - Mátraháza, Hungary, 3200
    - Not yet recruiting
    - Research Site
  - Gödöllő, Hungary, 2100
    - Suspended
    - Research Site
  - Hajdúnánás, Hungary, 4080
    - Not yet recruiting
    - Research Site
  - Kalocsa, Hungary, 6300
    - Not yet recruiting
    - Research Site
  - Komádi, Hungary, 4138
    - Not yet recruiting
    - Research Site
  - Monor, Hungary, 2200
    - Not yet recruiting
    - Research Site
  - Pécs, Hungary, 7626
    - Not yet recruiting
    - Research Site
  - Püspökladány, Hungary, 4150
    - Not yet recruiting
    - Research Site
  - Szolnok, Hungary, 5000
    - Not yet recruiting
    - Research Site
  - Százhalombatta, Hungary, 2440
    - Not yet recruiting
    - Research Site
  - Székesfehérvár, Hungary, 8000
    - Not yet recruiting
    - Research Site
  - Tapolca, Hungary, 8300
    - Not yet recruiting
    - Research Site
India
- - Aligarh, India, 202002
    - Not yet recruiting
    - Research Site
  - Belagavi, India, 590010
    - Not yet recruiting
    - Research Site
  - Dehradun, India, 248001
    - Not yet recruiting
    - Research Site
  - Delhi, India, 110029
    - Not yet recruiting
    - Research Site
  - Hyderabad, India, 500068
    - Not yet recruiting
    - Research Site
  - Mangalore, India, 575003
    - Not yet recruiting
    - Research Site
Italy
- - Ancona, Italy, 60100
    - Not yet recruiting
    - Research Site
  - Firenze, Italy, 50134
    - Not yet recruiting
    - Research Site
  - Genoa, Italy, 16132
    - Not yet recruiting
    - Research Site
  - Mestre, Italy, 30174
    - Not yet recruiting
    - Research Site
  - Milano, Italy, 20123
    - Not yet recruiting
    - Research Site
  - Modena, Italy, 41124
    - Not yet recruiting
    - Research Site
  - Napoli, Italy, 80131
    - Not yet recruiting
    - Research Site
  - Pavia, Italy, 27100
    - Not yet recruiting
    - Research Site
  - Perugia, Italy, 06126
    - Not yet recruiting
    - Research Site
  - Roma, Italy, 00128
    - Not yet recruiting
    - Research Site
  - Roma, Italy, 161
    - Not yet recruiting
    - Research Site
  - Roma, Italy, 00133
    - Not yet recruiting
    - Research Site
  - Rome, Italy, 00189
    - Not yet recruiting
    - Research Site
  - Siena, Italy, 53100
    - Not yet recruiting
    - Research Site
  - Varese, Italy, 21100
    - Not yet recruiting
    - Research Site
Japan
- - Fujieda-shi, Japan, 426-8677
    - Not yet recruiting
    - Research Site
  - Kitakyusyu, Japan, 802-0052
    - Not yet recruiting
    - Research Site
  - Kobe-shi, Japan, 651-0072
    - Not yet recruiting
    - Research Site
  - Kure-shi, Japan, 737-0193
    - Not yet recruiting
    - Research Site
  - Kyoto-shi, Japan, 607-8062
    - Not yet recruiting
    - Research Site
  - Mizunami-shi, Japan, 509-6134
    - Not yet recruiting
    - Research Site
  - Osaka-shi, Japan, 530-0012
    - Not yet recruiting
    - Research Site
  - Shinjuku-ku, Japan, 162-8655
    - Not yet recruiting
    - Research Site
  - Takamatsu-shi, Japan, 761-8073
    - Not yet recruiting
    - Research Site
  - Yamagata-shi, Japan, 990-8533
    - Not yet recruiting
    - Research Site
  - Yanagawa-shi, Japan, 832-0059
    - Not yet recruiting
    - Research Site
  - Yokohama-shi, Japan, 234-0054
    - Not yet recruiting
    - Research Site
Korea, Republic of
- - Daegu, Korea, Republic of, 42415
    - Not yet recruiting
    - Research Site
  - Guri-si, Korea, Republic of, 11923
    - Not yet recruiting
    - Research Site
  - Jeonju, Korea, Republic of, 54907
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 06591
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 04763
    - Not yet recruiting
    - Research Site
  - Seoul, Korea, Republic of, 03312
    - Not yet recruiting
    - Research Site
  - Ulsan, Korea, Republic of, 44033
    - Not yet recruiting
    - Research Site
Malaysia
- - Alor Setar, Malaysia, 05460
    - Not yet recruiting
    - Research Site
  - Kajang, Malaysia, 43000
    - Not yet recruiting
    - Research Site
  - Kuala Lumpur, Malaysia, 50586
    - Not yet recruiting
    - Research Site
  - Kuala Pilah, Malaysia, 72000
    - Not yet recruiting
    - Research Site
  - Sandakan, Malaysia, 90000
    - Not yet recruiting
    - Research Site
  - Sarawak Miri, Malaysia, 98000
    - Not yet recruiting
    - Research Site
  - Seremban, Malaysia, 70300
    - Not yet recruiting
    - Research Site
  - Sibu, Malaysia, 96000
    - Not yet recruiting
    - Research Site
Mexico
- - Benito Juarez, Mexico, 03650
    - Not yet recruiting
    - Research Site
  - Chihuahua, Mexico, 31000
    - Not yet recruiting
    - Research Site
  - Cuernavaca, Mexico, 62290
    - Not yet recruiting
    - Research Site
  - Culiacan, Mexico, 80020
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44200
    - Not yet recruiting
    - Research Site
  - Guadalajara, Mexico, 44670
    - Not yet recruiting
    - Research Site
  - Juriquilla, Mexico, 76320
    - Not yet recruiting
    - Research Site
  - Merida, Mexico, 97130
    - Not yet recruiting
    - Research Site
  - Metepec, Mexico, 52170
    - Not yet recruiting
    - Research Site
  - Mexico City, Mexico, 03310
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64460
    - Not yet recruiting
    - Research Site
  - Monterrey, Mexico, 64310
    - Not yet recruiting
    - Research Site
  - Oaxaca, Mexico, 68020
    - Not yet recruiting
    - Research Site
  - Tijuana, Mexico, 22010
    - Not yet recruiting
    - Research Site
  - Veracruz, Mexico, 91910
    - Not yet recruiting
    - Research Site
  - Xalapa, Mexico, 91193
    - Not yet recruiting
    - Research Site
  - Zapopan, Mexico, 45138
    - Not yet recruiting
    - Research Site
Norway
- - Kongsberg, Norway, 3612
    - Not yet recruiting
    - Research Site
  - Lørenskog, Norway, 1478
    - Not yet recruiting
    - Research Site
  - Trondheim, Norway, 7030
    - Not yet recruiting
    - Research Site
Peru
- - Concepción Del Uruguay, Peru, 3260
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15023
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15046
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 01
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15088
    - Not yet recruiting
    - Research Site
  - Lima, Peru, L18
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 21
    - Not yet recruiting
    - Research Site
  - Lima, Peru, LIMA 1
    - Not yet recruiting
    - Research Site
  - Lima, Peru, L27
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15102
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15324
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15024
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 15131
    - Not yet recruiting
    - Research Site
  - Lima, Peru, 33
    - Not yet recruiting
    - Research Site
  - Piura, Peru, 20001
    - Not yet recruiting
    - Research Site
  - el Agustino, Peru, LIMA 10
    - Not yet recruiting
    - Research Site
Philippines
- - Iloilo City, Philippines, 5000
    - Not yet recruiting
    - Research Site
  - Las Pinas, Philippines, 1742
    - Not yet recruiting
    - Research Site
  - Manila, Philippines, 1000
    - Not yet recruiting
    - Research Site
  - Marilao, Philippines, 3019
    - Not yet recruiting
    - Research Site
  - Puerto Princesa City, Philippines, 5300
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 1109
    - Not yet recruiting
    - Research Site
  - Quezon City, Philippines, 0870
    - Not yet recruiting
    - Research Site
  - Roxas City, Philippines, 5800
    - Not yet recruiting
    - Research Site
  - Tondo, Philippines, 1012
    - Not yet recruiting
    - Research Site
Poland
- - Bialystok, Poland, 15-879
    - Not yet recruiting
    - Research Site
  - Bydgoszcz, Poland, 85-796
    - Not yet recruiting
    - Research Site
  - Chojnice, Poland, 89-600
    - Not yet recruiting
    - Research Site
  - Godziesze Małe, Poland, 62-872
    - Not yet recruiting
    - Research Site
  - Inowrocław, Poland, 88-100
    - Not yet recruiting
    - Research Site
  - Karczew, Poland, 05-480
    - Not yet recruiting
    - Research Site
  - Katowice, Poland, 40-081
    - Not yet recruiting
    - Research Site
  - Katowice, Poland, 40-648
    - Not yet recruiting
    - Research Site
  - Kielce, Poland, 25-734
    - Not yet recruiting
    - Research Site
  - Kielce, Poland, 25-751
    - Not yet recruiting
    - Research Site
  - Kielce, Poland, 25-426
    - Not yet recruiting
    - Research Site
  - Krakow, Poland, 31-501
    - Not yet recruiting
    - Research Site
  - Kraków, Poland, 31-513
    - Not yet recruiting
    - Research Site
  - Libiąż, Poland, 32-590
    - Not yet recruiting
    - Research Site
  - Lubin, Poland, 59-300
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-601
    - Not yet recruiting
    - Research Site
  - Lublin, Poland, 20-078
    - Not yet recruiting
    - Research Site
  - Ostrowiec Świętokrzyski, Poland, 27-400
    - Not yet recruiting
    - Research Site
  - Piaseczno, Poland, 05-500
    - Not yet recruiting
    - Research Site
  - Poznań, Poland, 61-578
    - Not yet recruiting
    - Research Site
  - Płock, Poland, 09-407
    - Not yet recruiting
    - Research Site
  - Rzeszów, Poland, 35-205
    - Not yet recruiting
    - Research Site
  - Skórzewo, Poland, 60-185
    - Not yet recruiting
    - Research Site
  - Sochaczew, Poland, 96-500
    - Not yet recruiting
    - Research Site
  - Sosnowiec, Poland, 41-208
    - Not yet recruiting
    - Research Site
  - Sosnowiec, Poland, 41-200
    - Suspended
    - Research Site
  - Szczecin, Poland, 70-111
    - Not yet recruiting
    - Research Site
  - Słupsk, Poland, 76-200
    - Not yet recruiting
    - Research Site
  - Toruń, Poland, 87-100
    - Not yet recruiting
    - Research Site
  - Ustroń, Poland, 43-450
    - Not yet recruiting
    - Research Site
  - Warszawa, Poland, 00-215
    - Not yet recruiting
    - Research Site
  - Wrocław, Poland, 53-673
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 91-363
    - Not yet recruiting
    - Research Site
  - Łódź, Poland, 92-003
    - Not yet recruiting
    - Research Site
Romania
- - Bucharest, Romania, 011461
    - Not yet recruiting
    - Research Site
  - Bucharest, Romania, 050159
    - Not yet recruiting
    - Research Site
  - Cluj-Napoca, Romania, 400371
    - Not yet recruiting
    - Research Site
  - Leamna de Sus, Romania, 207129
    - Not yet recruiting
    - Research Site
  - Targu Mures, Romania, 540098
    - Not yet recruiting
    - Research Site
  - Timisoara, Romania, 300310
    - Not yet recruiting
    - Research Site
Serbia
- - Belgrade, Serbia, 11000
    - Not yet recruiting
    - Research Site
Slovakia
- - Brezno, Slovakia, 977 01
    - Not yet recruiting
    - Research Site
  - Humenne, Slovakia, 066 01
    - Not yet recruiting
    - Research Site
  - Kosice, Slovakia, 04022
    - Not yet recruiting
    - Research Site
  - Kráľovský Chlmec, Slovakia, 077 01
    - Not yet recruiting
    - Research Site
  - Levice, Slovakia, 93401
    - Not yet recruiting
    - Research Site
  - Presov, Slovakia, 081 81
    - Not yet recruiting
    - Research Site
  - Topoľčany, Slovakia, 955 01
    - Not yet recruiting
    - Research Site
Spain
- - Badia Del Vallès, Spain, 08214
    - Not yet recruiting
    - Research Site
  - Barakaldo, Spain, 48903
    - Not yet recruiting
    - Research Site
  - Barcelona, Spain, 08017
    - Not yet recruiting
    - Research Site
  - Cabra, Spain, 14940
    - Not yet recruiting
    - Research Site
  - Castro Urdiales, Spain, 39700
    - Not yet recruiting
    - Research Site
  - Granada, Spain, 18014
    - Not yet recruiting
    - Research Site
  - Madrid, Spain, 28031
    - Not yet recruiting
    - Research Site
  - Marbella (Málaga), Spain, 29603
    - Not yet recruiting
    - Research Site
  - Mataró, Spain, 08302
    - Not yet recruiting
    - Research Site
  - Mataró, Spain, 08303
    - Not yet recruiting
    - Research Site
  - Málaga, Spain, 29010
    - Not yet recruiting
    - Research Site
  - Palma, Spain, 07011
    - Not yet recruiting
    - Research Site
  - Santiago De Compostela-Coruña, Spain, 15706
    - Not yet recruiting
    - Research Site
  - Tenerife, Spain, 38010
    - Not yet recruiting
    - Research Site
  - Viladecans, Spain, 08840
    - Not yet recruiting
    - Research Site
Sweden
- - Göteborg, Sweden, 413 46
    - Not yet recruiting
    - Research Site
  - Göteborg, Sweden, 41345
    - Not yet recruiting
    - Research Site
  - Höllviken, Sweden, 236 51
    - Not yet recruiting
    - Research Site
  - Kungsbacka, Sweden, 434 80
    - Not yet recruiting
    - Research Site
  - Lund, Sweden, 22242
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 171 76
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 117 27
    - Not yet recruiting
    - Research Site
  - Stockholm, Sweden, 11883
    - Not yet recruiting
    - Research Site
  - Umeå, Sweden, 90187
    - Not yet recruiting
    - Research Site
  - Örebro, Sweden, 70185
    - Not yet recruiting
    - Research Site
Taiwan
- - Kao Hsiung, Taiwan, TAIWAN
    - Not yet recruiting
    - Research Site
  - Kaohsiung, Taiwan, 82445
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40201
    - Not yet recruiting
    - Research Site
  - Taichung, Taiwan, 40705
    - Not yet recruiting
    - Research Site
  - Tainan City, Taiwan, 70403
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 10002
    - Not yet recruiting
    - Research Site
  - Taipei, Taiwan, 10449
    - Not yet recruiting
    - Research Site
  - Taoyuan, Taiwan, 00333
    - Not yet recruiting
    - Research Site
  - Taoyuan City, Taiwan, 330
    - Not yet recruiting
    - Research Site
  - Yunlin, Taiwan, 640
    - Not yet recruiting
    - Research Site
Thailand
- - Bang Kra So, Thailand, 11000
    - Not yet recruiting
    - Research Site
  - Bangkok, Thailand, 10700
    - Not yet recruiting
    - Research Site
  - Hat Yai, Thailand, 90110
    - Not yet recruiting
    - Research Site
  - Khlong Luang, Thailand, 12120
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 50200
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 40002
    - Not yet recruiting
    - Research Site
  - Muang, Thailand, 22000
    - Not yet recruiting
    - Research Site
  - Ongkharak, Thailand, 26120
    - Not yet recruiting
    - Research Site
  - Phitsanulok, Thailand, 65000
    - Not yet recruiting
    - Research Site
  - Ratchathewi, Thailand, 10400
    - Not yet recruiting
    - Research Site
Turkey
- - Adana, Turkey, 01330
    - Not yet recruiting
    - Research Site
  - Adana, Turkey, 01060
    - Not yet recruiting
    - Research Site
  - Afyonkarahisar, Turkey, 03030
    - Not yet recruiting
    - Research Site
  - Antalya, Turkey, 07059
    - Not yet recruiting
    - Research Site
  - Bursa, Turkey, 16059
    - Not yet recruiting
    - Research Site
  - Bursa, Turkey, 16110
    - Not yet recruiting
    - Research Site
  - Canakkale, Turkey, 17110
    - Not yet recruiting
    - Research Site
  - Isparta, Turkey, 32260
    - Not yet recruiting
    - Research Site
  - Istanbul, Turkey, 34785
    - Not yet recruiting
    - Research Site
  - Izmir, Turkey, 35965
    - Not yet recruiting
    - Research Site
  - Kocaeli, Turkey, 41380
    - Not yet recruiting
    - Research Site
  - Mersin, Turkey, 33343
    - Not yet recruiting
    - Research Site
  - Tekirdag, Turkey, 59030
    - Not yet recruiting
    - Research Site
  - Zeytinburnu, Turkey, 34020
    - Not yet recruiting
    - Research Site
  - Çankaya, Turkey, 06700
    - Not yet recruiting
    - Research Site
  - İstanbul, Turkey, 34844
    - Not yet recruiting
    - Research Site
United Kingdom
- - Bicester, United Kingdom, OX26 6AT
    - Not yet recruiting
    - Research Site
  - Bollington, United Kingdom, SK10 5JH
    - Not yet recruiting
    - Research Site
  - Chesterfield, United Kingdom, S40 4AA
    - Not yet recruiting
    - Research Site
  - Corby, United Kingdom, NN17 2UR
    - Not yet recruiting
    - Research Site
  - Fowey, United Kingdom, PL23 1DT
    - Not yet recruiting
    - Research Site
  - Hownslow, United Kingdom, TW3 3LN
    - Not yet recruiting
    - Research Site
  - Liverpool, United Kingdom, L14 3PE
    - Not yet recruiting
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Not yet recruiting
    - Research Site
  - Newquay, United Kingdom, TR7 1RU
    - Not yet recruiting
    - Research Site
  - North Somerset, United Kingdom, BS23 3HQ
    - Not yet recruiting
    - Research Site
  - Northallerton, United Kingdom, DL7 8AW
    - Not yet recruiting
    - Research Site
  - Norwich, United Kingdom, NR1 1RB
    - Not yet recruiting
    - Research Site
  - Nottingham, United Kingdom, NG9 6DX
    - Not yet recruiting
    - Research Site
  - Perth, United Kingdom, PH1 1NX
    - Not yet recruiting
    - Research Site
  - Poole, United Kingdom, BH16 5PW
    - Not yet recruiting
    - Research Site
  - Sheffield, United Kingdom, S9 4EU
    - Not yet recruiting
    - Research Site
  - Torbay, United Kingdom, TQ1 4QX
    - Not yet recruiting
    - Research Site
  - Whitney, United Kingdom, OX29 4QB
    - Not yet recruiting
    - Research Site
  - Witney, United Kingdom, OX28 6JS
    - Not yet recruiting
    - Research Site
United States
- Alabama
  - Athens, Alabama, United States, 35611
    - Not yet recruiting
    - Research Site
  - Cullman, Alabama, United States, 35058
    - Not yet recruiting
    - Research Site
  - Fairhope, Alabama, United States, 36532
    - Recruiting
    - Research Site
  - Huntsville, Alabama, United States, 35801
    - Not yet recruiting
    - Research Site
  - Mobile, Alabama, United States, 36608
    - Not yet recruiting
    - Research Site
  - Sheffield, Alabama, United States, 35660
    - Not yet recruiting
    - Research Site
- Arizona
  - Gilbert, Arizona, United States, 85296
    - Not yet recruiting
    - Research Site
  - Glendale, Arizona, United States, 85308
    - Not yet recruiting
    - Research Site
  - Mesa, Arizona, United States, 85213
    - Not yet recruiting
    - Research Site
  - Mesa, Arizona, United States, 85206
    - Recruiting
    - Research Site
  - Phoenix, Arizona, United States, 85006
    - Not yet recruiting
    - Research Site
  - Tempe, Arizona, United States, 85283
    - Not yet recruiting
    - Research Site
  - Tempe, Arizona, United States, 85281
    - Not yet recruiting
    - Research Site
  - Tucson, Arizona, United States, 85710
    - Not yet recruiting
    - Research Site
- California
  - Apple Valley, California, United States, 92307
    - Not yet recruiting
    - Research Site
  - Banning, California, United States, 92220
    - Not yet recruiting
    - Research Site
  - Canoga Park, California, United States, 91303
    - Not yet recruiting
    - Research Site
  - Garden Grove, California, United States, 92844
    - Not yet recruiting
    - Research Site
  - Gardena, California, United States, 90247
    - Not yet recruiting
    - Research Site
  - Inglewood, California, United States, 90301
    - Not yet recruiting
    - Research Site
  - La Mesa, California, United States, 91942
    - Not yet recruiting
    - Research Site
  - La Palma, California, United States, 90623
    - Not yet recruiting
    - Research Site
  - Lomita, California, United States, 90717
    - Not yet recruiting
    - Research Site
  - Los Alamitos, California, United States, 90720
    - Not yet recruiting
    - Research Site
  - Newport Beach, California, United States, 92663
    - Recruiting
    - Research Site
  - Newport Beach, California, United States, 92660
    - Not yet recruiting
    - Research Site
  - North Hollywood, California, United States, 91602
    - Not yet recruiting
    - Research Site
  - Panorama City, California, United States, 91402
    - Not yet recruiting
    - Research Site
  - Pomona, California, United States, 91768
    - Not yet recruiting
    - Research Site
  - Sacramento, California, United States, 95823
    - Not yet recruiting
    - Research Site
  - Sacramento, California, United States, 95831
    - Not yet recruiting
    - Research Site
  - Salinas, California, United States, 93901
    - Not yet recruiting
    - Research Site
  - San Diego, California, United States, 92111
    - Not yet recruiting
    - Research Site
  - San Dimas, California, United States, 91773
    - Not yet recruiting
    - Research Site
  - Santa Ana, California, United States, 92704
    - Not yet recruiting
    - Research Site
  - Tarzana, California, United States, 91356
    - Not yet recruiting
    - Research Site
  - Thousand Oaks, California, United States, 91360
    - Not yet recruiting
    - Research Site
  - Vista, California, United States, 92081
    - Not yet recruiting
    - Research Site
  - Westminster, California, United States, 92683
    - Not yet recruiting
    - Research Site
- Colorado
  - Aurora, Colorado, United States, 80012
    - Not yet recruiting
    - Research Site
  - Denver, Colorado, United States, 80228
    - Not yet recruiting
    - Research Site
  - Denver, Colorado, United States, 80224
    - Not yet recruiting
    - Research Site
- District of Columbia
  - Washington, District of Columbia, United States, 20016
    - Not yet recruiting
    - Research Site
- Florida
  - Boynton Beach, Florida, United States, 33435
    - Not yet recruiting
    - Research Site
  - Bradenton, Florida, United States, 34208
    - Not yet recruiting
    - Research Site
  - Cape Coral, Florida, United States, 33990
    - Not yet recruiting
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Not yet recruiting
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Not yet recruiting
    - Research Site
  - Crystal River, Florida, United States, 34429
    - Not yet recruiting
    - Research Site
  - Cutler Bay, Florida, United States, 33189
    - Not yet recruiting
    - Research Site
  - Edgewater, Florida, United States, 32132
    - Not yet recruiting
    - Research Site
  - Fort Lauderdale, Florida, United States, 33308
    - Not yet recruiting
    - Research Site
  - Fort Myers, Florida, United States, 33912
    - Not yet recruiting
    - Research Site
  - Hialeah, Florida, United States, 33013
    - Not yet recruiting
    - Research Site
  - Hollywood, Florida, United States, 33024
    - Not yet recruiting
    - Research Site
  - Kissimmee, Florida, United States, 34741
    - Not yet recruiting
    - Research Site
  - Kissimmee, Florida, United States, 34746
    - Not yet recruiting
    - Research Site
  - Lake City, Florida, United States, 32055
    - Not yet recruiting
    - Research Site
  - Lake Worth, Florida, United States, 33467
    - Not yet recruiting
    - Research Site
  - Lakeland, Florida, United States, 33813
    - Not yet recruiting
    - Research Site
  - Loxahatchee Groves, Florida, United States, 33470
    - Not yet recruiting
    - Research Site
  - Miami, Florida, United States, 33155
    - Not yet recruiting
    - Research Site
  - Miami, Florida, United States, 33175
    - Recruiting
    - Research Site
  - Miami, Florida, United States, 33256
    - Not yet recruiting
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Not yet recruiting
    - Research Site
  - Naples, Florida, United States, 34102
    - Not yet recruiting
    - Research Site
  - Ocala, Florida, United States, 34470
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32825
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32807
    - Not yet recruiting
    - Research Site
  - Orlando, Florida, United States, 32819
    - Not yet recruiting
    - Research Site
  - Ormond Beach, Florida, United States, 32174
    - Not yet recruiting
    - Research Site
  - Pembroke Pines, Florida, United States, 33024
    - Not yet recruiting
    - Research Site
  - Plantation, Florida, United States, 33324
    - Not yet recruiting
    - Research Site
  - Saint Petersburg, Florida, United States, 33713
    - Not yet recruiting
    - Research Site
  - Sun City Center, Florida, United States, 33573
    - Not yet recruiting
    - Research Site
  - Tamarac, Florida, United States, 33321
    - Not yet recruiting
    - Research Site
  - Tampa, Florida, United States, 33606
    - Not yet recruiting
    - Research Site
  - Tampa, Florida, United States, 33607
    - Not yet recruiting
    - Research Site
  - Tampa, Florida, United States, 33625
    - Not yet recruiting
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30349
    - Not yet recruiting
    - Research Site
  - Buford, Georgia, United States, 30519
    - Not yet recruiting
    - Research Site
  - Peachtree Corners, Georgia, United States, 30092
    - Not yet recruiting
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Not yet recruiting
    - Research Site
- Idaho
  - Boise, Idaho, United States, 83706
    - Not yet recruiting
    - Research Site
- Illinois
  - Chicago, Illinois, United States, 60607
    - Not yet recruiting
    - Research Site
  - Winfield, Illinois, United States, 60190
    - Not yet recruiting
    - Research Site
- Indiana
  - Valparaiso, Indiana, United States, 46383
    - Not yet recruiting
    - Research Site
- Kansas
  - Newton, Kansas, United States, 67114
    - Not yet recruiting
    - Research Site
  - Wichita, Kansas, United States, 67218
    - Not yet recruiting
    - Research Site
- Kentucky
  - Lexington, Kentucky, United States, 40503
    - Not yet recruiting
    - Research Site
  - Paducah, Kentucky, United States, 42001
    - Not yet recruiting
    - Research Site
- Louisiana
  - Lafayette, Louisiana, United States, 70508
    - Not yet recruiting
    - Research Site
  - Monroe, Louisiana, United States, 71201
    - Not yet recruiting
    - Research Site
  - Shreveport, Louisiana, United States, 71105
    - Recruiting
    - Research Site
  - Zachary, Louisiana, United States, 70791
    - Not yet recruiting
    - Research Site
- Maryland
  - Oxon Hill, Maryland, United States, 20745
    - Not yet recruiting
    - Research Site
  - Potomac, Maryland, United States, 20854
    - Not yet recruiting
    - Research Site
- Massachusetts
  - Boston, Massachusetts, United States, 02115
    - Not yet recruiting
    - Research Site
- Michigan
  - Flint, Michigan, United States, 48504
    - Not yet recruiting
    - Research Site
  - Lathrup Village, Michigan, United States, 48076
    - Not yet recruiting
    - Research Site
  - Southfield, Michigan, United States, 48034
    - Not yet recruiting
    - Research Site
- Mississippi
  - Gulfport, Mississippi, United States, 39503
    - Recruiting
    - Research Site
  - Olive Branch, Mississippi, United States, 38654
    - Not yet recruiting
    - Research Site
- Missouri
  - Kansas City, Missouri, United States, 64116
    - Not yet recruiting
    - Research Site
  - Liberty, Missouri, United States, 64068
    - Not yet recruiting
    - Research Site
  - Saint Louis, Missouri, United States, 63136
    - Not yet recruiting
    - Research Site
- Montana
  - Missoula, Montana, United States, 59808
    - Recruiting
    - Research Site
- Nebraska
  - Fremont, Nebraska, United States, 68025
    - Not yet recruiting
    - Research Site
  - Grand Island, Nebraska, United States, 68803
    - Not yet recruiting
    - Research Site
  - Omaha, Nebraska, United States, 68134
    - Not yet recruiting
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89102
    - Not yet recruiting
    - Research Site
  - Las Vegas, Nevada, United States, 89101
    - Not yet recruiting
    - Research Site
  - Las Vegas, Nevada, United States, 89119
    - Not yet recruiting
    - Research Site
- New Jersey
  - Lawrence Township, New Jersey, United States, 08648
    - Not yet recruiting
    - Research Site
  - Mullica Hill, New Jersey, United States, 08062
    - Not yet recruiting
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Not yet 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
    - Not yet recruiting
    - Research Site
  - Bronx, New York, United States, 10455
    - Recruiting
    - Research Site
  - Bronxville, New York, United States, 10708
    - Not yet recruiting
    - Research Site
  - Massapequa, New York, United States, 11758
    - Not yet recruiting
    - Research Site
  - New Windsor, New York, United States, 12553
    - Not yet recruiting
    - Research Site
  - New York, New York, United States, 10036
    - Not yet recruiting
    - Research Site
  - Vestal, New York, United States, 13850
    - Not yet recruiting
    - Research Site
- North Carolina
  - Fayetteville, North Carolina, United States, 28303
    - Not yet recruiting
    - Research Site
  - Greensboro, North Carolina, United States, 27405
    - Not yet recruiting
    - Research Site
  - Greenville, North Carolina, United States, 27834
    - Not yet recruiting
    - Research Site
  - Huntersville, North Carolina, United States, 28078
    - Not yet recruiting
    - Research Site
  - Morehead City, North Carolina, United States, 28557
    - Not yet recruiting
    - Research Site
  - Raleigh, North Carolina, United States, 27612
    - Not yet recruiting
    - Research Site
  - Salisbury, North Carolina, United States, 28144
    - Not yet recruiting
    - Research Site
  - Statesville, North Carolina, United States, 28625
    - Not yet recruiting
    - Research Site
  - Statesville, North Carolina, United States, 28677
    - Not yet recruiting
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Not yet recruiting
    - Research Site
- Ohio
  - Beavercreek, Ohio, United States, 45431
    - Not yet recruiting
    - Research Site
  - Blue Ash, Ohio, United States, 45242
    - Not yet recruiting
    - Research Site
  - Cleveland, Ohio, United States, 44130
    - Not yet recruiting
    - Research Site
  - Columbus, Ohio, United States, 43215
    - Recruiting
    - Research Site
  - Columbus, Ohio, United States, 43235
    - Not yet recruiting
    - Research Site
  - Marion, Ohio, United States, 43302
    - Not yet recruiting
    - Research Site
  - Toledo, Ohio, United States, 43617
    - Not yet recruiting
    - Research Site
- Oklahoma
  - Norman, Oklahoma, United States, 73071
    - Not yet recruiting
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73134
    - Not yet recruiting
    - Research Site
  - Tulsa, Oklahoma, United States, 74133
    - Not yet recruiting
    - Research Site
- Oregon
  - Grants Pass, Oregon, United States, 97527
    - Not yet recruiting
    - Research Site
  - Medford, Oregon, United States, 97504
    - Not yet recruiting
    - Research Site
  - Roseburg, Oregon, United States, 97471
    - Not yet recruiting
    - Research Site
- Pennsylvania
  - Camp Hill, Pennsylvania, United States, 17011
    - Not yet recruiting
    - Research Site
  - DuBois, Pennsylvania, United States, 15801
    - Not yet recruiting
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19140
    - Not yet recruiting
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Recruiting
    - Research Site
  - Charleston, South Carolina, United States, 29414
    - Not yet recruiting
    - Research Site
  - Columbia, South Carolina, United States, 29201
    - Not yet recruiting
    - Research Site
  - Gaffney, South Carolina, United States, 29340
    - Recruiting
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Not yet recruiting
    - Research Site
  - Union, South Carolina, United States, 29379
    - Recruiting
    - Research Site
- South Dakota
  - North Sioux City, South Dakota, United States, 57049
    - Not yet recruiting
    - Research Site
  - Rapid City, South Dakota, United States, 57701
    - Not yet recruiting
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37421
    - Not yet recruiting
    - Research Site
  - Elizabethton, Tennessee, United States, 37643
    - Not yet recruiting
    - Research Site
  - Franklin, Tennessee, United States, 37067
    - Not yet recruiting
    - Research Site
  - Morristown, Tennessee, United States, 37813
    - Not yet recruiting
    - Research Site
  - Tullahoma, Tennessee, United States, 37388
    - Recruiting
    - Research Site
- Texas
  - Abilene, Texas, United States, 79606
    - Not yet recruiting
    - Research Site
  - Amarillo, Texas, United States, 79106
    - Not yet recruiting
    - Research Site
  - Austin, Texas, United States, 78704
    - Not yet recruiting
    - Research Site
  - Brownsville, Texas, United States, 78520
    - Not yet recruiting
    - Research Site
  - Dallas, Texas, United States, 75235
    - Not yet recruiting
    - Research Site
  - Dallas, Texas, United States, 75225
    - Not yet recruiting
    - Research Site
  - Denison, Texas, United States, 75020
    - Not yet recruiting
    - Research Site
  - El Paso, Texas, United States, 79902
    - Not yet recruiting
    - Research Site
  - Forney, Texas, United States, 75126
    - Not yet recruiting
    - Research Site
  - Georgetown, Texas, United States, 78633
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77089
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77024
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77079
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77074
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77002
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77025
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77029
    - Not yet recruiting
    - Research Site
  - Houston, Texas, United States, 77084
    - Recruiting
    - Research Site
  - Houston, Texas, United States, 77207
    - Not yet recruiting
    - Research Site
  - Katy, Texas, United States, 77450
    - Not yet recruiting
    - Research Site
  - Katy, Texas, United States, 77493
    - Not yet recruiting
    - Research Site
  - Kerrville, Texas, United States, 78028
    - Not yet recruiting
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Not yet recruiting
    - Research Site
  - Lewisville, Texas, United States, 75057
    - Not yet recruiting
    - Research Site
  - McAllen, Texas, United States, 78504
    - Not yet recruiting
    - Research Site
  - McKinney, Texas, United States, 75069
    - Not yet recruiting
    - Research Site
  - Paris, Texas, United States, 75462
    - Not yet recruiting
    - Research Site
  - Plano, Texas, United States, 75024
    - Not yet recruiting
    - Research Site
  - Waco, Texas, United States, 76708
    - Not yet recruiting
    - Research Site
  - Wichita Falls, Texas, United States, 76308
    - Not yet recruiting
    - Research Site
  - Wylie, Texas, United States, 75098
    - Not yet recruiting
    - Research Site
- Utah
  - Bountiful, Utah, United States, 84010
    - Not yet recruiting
    - Research Site
  - Ogden, Utah, United States, 84405
    - Not yet recruiting
    - Research Site
  - Salt Lake City, Utah, United States, 84107
    - Not yet recruiting
    - Research Site
  - West Jordan, Utah, United States, 84088
    - Not yet recruiting
    - Research Site
  - West Valley City, Utah, United States, 84120
    - Not yet recruiting
    - Research Site
- Virginia
  - Newport News, Virginia, United States, 23606
    - Not yet recruiting
    - Research Site
  - Norfolk, Virginia, United States, 23504
    - Not yet recruiting
    - Research Site
  - Portsmouth, Virginia, United States, 23703
    - Not yet recruiting
    - Research Site
  - Richmond, Virginia, United States, 23219
    - Not yet recruiting
    - Research Site
- Washington
  - Spokane, Washington, United States, 99218
    - Recruiting
    - Research Site
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - Not yet recruiting
    - Research Site
- Wisconsin
  - Cudahy, Wisconsin, United States, 53110
    - Not yet recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53295
    - Not yet recruiting
    - Research Site
  - Milwaukee, Wisconsin, United States, 53228
    - Not yet recruiting
    - 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

Description

Inclusion Criteria:

Male or female participants must be 40 to 80 years of age inclusive, at the time of signing
the ICF.
Demonstrate acceptable MDI administration technique at Visit 1 (V1) and Visit 2 (V2)
A diagnosis of COPD confirmed by a post-bronchodilator FEV1/FVC ratio < 70%
at V1.
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.
A baseline peripheral blood eosinophil count of ≥ 100 cells/mm3 assessed at Visit 1 by
the central laboratory
A CAT score of ≥ 10 at Visit 1.
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
Willing and, in the opinion of the investigator, able to adjust current COPD therapy, as
required by the protocol.
Willing to visit at the study site or participate in virtual visits as required per the protocol
to complete all study assessments.
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.
Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Exclusion Criteria:

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.
End-stage renal disease requiring renal replacement therapy
History of heart or lung transplant or actively listed for heart or lung transplant.
Implanted left ventricular assist device or implant anticipated in < 3 months.
History of lung cancer and/or treatment for lung cancer within the 5 years prior to Visit 1.
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.
Pneumonia and/or moderate or severe COPD exacerbation that has not resolved at least 8 weeks prior to Visit 1
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.
Use of maintenance ICS treatment within the past 12 months.
Unable to abstain from protocol-defined prohibited medications
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).
Participants with a known hypersensitivity to LAMA, LABA or ICS or any component of the MDI.
Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).
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.
Previous randomization in the present study.
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

Number of Arms

Arms and Interventions

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

AstraZeneca

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)

March 6, 2028

Study Completion (Estimated)

March 6, 2028

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)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

D5989C00001

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

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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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Other Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on COPD (Chronic Obstructive Pulmonary Disease)

Clinical Trials on BGF MDI 320/14.4/9.6 μg

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malaysia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations