Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)

February 1, 2021 updated by: Pearl Therapeutics, Inc.

A Randomized, Double-Blind, Multi-Center, Parallel-Group Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 on COPD Exacerbations Over a 52-Week Treatment Period in Subjects With Moderate to Very Severe COPD (Ethos)

This is a randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations subjects with moderate to very severe COPD.

Study Overview

Status

Completed

Conditions

COPD

Intervention / Treatment

Detailed Description

A randomized, double-blind, multi-center, parallel-group study to assess the efficacy and safety of PT010 relative to PT003 and PT009 on COPD exacerbations over a 52-week treatment period in subjects with moderate to very severe COPD.

Study Type

Interventional

Enrollment (Actual)

8588

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, C1414AIF
    - Research Site
  - Buenos Aires, Argentina, C1121ABE
    - Research Site
  - Buenos Aires, Argentina, C1425BEN
    - Research Site
  - Buenos Aires, Argentina, 1015
    - Research Site
  - Caba, Argentina, C1056ABJ
    - Research Site
  - Capital Federal, Argentina, C1122AAK
    - Research Site
  - Ciudad Autonoma de Buenos Aire, Argentina, C1120AAC
    - Research Site
  - Ciudad Autonoma de Buenos Aire, Argentina, C1028AAP
    - Research Site
  - Ciudad Autonomade Buenos Aires, Argentina, 1426
    - Research Site
  - Ciudad Autónoma de Bs. As., Argentina, 1426
    - Research Site
  - Ciudad Capital, Argentina, 5500
    - Research Site
  - Ciudad de Buenos Aire, Argentina, C1425BEN
    - Research Site
  - Cordoba, Argentina, X5008HHW
    - Research Site
  - Córdoba, Argentina, X5003DCE
    - Research Site
  - Florencio Varela, Argentina, 1888
    - Research Site
  - Florida, Argentina, B1602DQD
    - Research Site
  - La Plata, Argentina, 1900
    - Research Site
  - Lanus, Argentina, B1824KAJ
    - Research Site
  - Mar del Plata, Argentina, 7600
    - Research Site
  - Mar del Plata, Argentina, B7600FZN
    - Research Site
  - Mendoza, Argentina, 5500
    - Research Site
  - Mendoza, Argentina, M5500GIP
    - Research Site
  - Mendoza, Argentina, M5500GPD
    - Research Site
  - Monte Grande, Argentina, 1842
    - Research Site
  - Paraná, Argentina, E3100XAI
    - Research Site
  - Quilmes, Argentina, B1878FNR
    - Research Site
  - Rosario, Argentina, 2000
    - Research Site
  - Rosario, Argentina, S2000DEJ
    - Research Site
  - Rosario, Argentina, 2002
    - Research Site
  - San Fernando, Argentina, 1646
    - Research Site
  - San Miguel de Tucuman, Argentina, 4000
    - Research Site
  - San Miguel de Tucumán, Argentina, T4000IAR
    - Research Site
  - Santa Fe, Argentina, S3000FWO
    - Research Site
  - Santa Fe, Argentina, S3000ASF
    - Research Site
  - Santa Rosa, Argentina, L6300EAN
    - Research Site
Australia
- - Adelaide, Australia, 5000
    - Research Site
  - Bedford Park, Australia, 5042
    - Research Site
  - Box Hill, Australia, 3128
    - Research Site
  - Cairns, Australia, 4870
    - Research Site
  - Concord, Australia, 2139
    - Research Site
  - Everton Park, Australia, 4053
    - Research Site
  - Kent Town, Australia, 5067
    - Research Site
  - Murdoch, Australia, 6150
    - Research Site
  - Nedlands, Australia, 6009
    - Research Site
  - South Brisbane, Australia, 4101
    - Research Site
  - Westmead, Australia, 2145
    - Research Site
Austria
- - Feldbach, Austria, A-8330
    - Research Site
  - Grieskirchen, Austria, 4710
    - Research Site
  - Hallein, Austria, 5400
    - Research Site
  - Linz, Austria, 04020
    - Research Site
  - Salzburg, Austria, 5020
    - Research Site
  - Thalheim, Austria, 4600
    - Research Site
  - Vienna, Austria, 1190
    - Research Site
  - Wels, Austria, 4600
    - Research Site
Belgium
- - Bruxelles, Belgium, 1200
    - Research Site
  - Erpent, Belgium, 5101
    - Research Site
  - Genk, Belgium, 03600
    - Research Site
  - Gilly, Belgium, 6060
    - Research Site
  - Halen, Belgium, 03545
    - Research Site
  - Ham, Belgium, 03945
    - Research Site
  - Lebbeke, Belgium
    - Research Site
  - Montigny Le Tilleul, Belgium, BE-6110
    - Research Site
  - Wetteren, Belgium, 9230
    - Research Site
Canada
- - Quebec, Canada, G1G 3Y8
    - Research Site
  - Quebec, Canada, G1V 4G5
    - Research Site
- Alberta
  - Edmonton, Alberta, Canada, T5A 4L8
    - Research Site
  - Sherwood Park, Alberta, Canada, T8L 0N2
    - Research Site
- British Columbia
  - Vancouver, British Columbia, Canada, V5X04
    - Research Site
- CA
  - Vancouver, CA, Canada, V5Z 4E1
    - Research Site
- Manitoba
  - Winnipeg, Manitoba, Canada, R2K 3S8
    - Research Site
- Nova Scotia
  - Truro, Nova Scotia, Canada, B2N 1L2
    - Research Site
- Ontario
  - Ajax, Ontario, Canada, L1S 2J5
    - Research Site
  - Burlington, Ontario, Canada, L7N 3V2
    - Research Site
  - Hamilton, Ontario, Canada, L8N 4A6
    - Research Site
  - Mississauga, Ontario, Canada, L4V 1P1
    - Research Site
  - Sarnia, Ontario, Canada, N7T4X3
    - Research Site
  - Sudbury, Ontario, Canada, P3A 1W8
    - Research Site
  - Windsor, Ontario, Canada, N8X 1T3
    - Research Site
- Quebec
  - Gatineau, Quebec, Canada, J8Y 6S8
    - Research Site
  - Levis, Quebec, Canada, G6W 0M5
    - Research Site
  - Mirabel, Quebec, Canada, J7J 2K8
    - Research Site
  - Montreal, Quebec, Canada, H1M 1B1
    - Research Site
  - Montreal, Quebec, Canada, H2X 1P1
    - Research Site
  - Pointe-Claire, Quebec, Canada, H9R 3J1
    - Research Site
  - Saint-Jerome, Quebec, Canada, J7Z 5T3
    - Research Site
  - St Charles Borromee, Quebec, Canada, J6E 2B4
    - Research Site
- Saskatchewan
  - Saskatoon, Saskatchewan, Canada, S7N 0W8
    - Research Site
Chile
- - Concepción, Chile, 4070038
    - Research Site
  - Curico, Chile, 3341643
    - Research Site
  - Quillota, Chile, 2260877
    - Research Site
  - Santiago, Chile, 7500698
    - Research Site
  - Santiago, Chile, 8910131
    - Research Site
  - Santiago, Chile, 8207257
    - Research Site
  - Santiago, Chile, 7750495
    - Research Site
  - Santiago, Chile, 8053095
    - Research Site
  - Santiago, Chile, 7500588
    - Research Site
  - Santiago, Chile, 7500692
    - Research Site
  - Talca, Chile, 3465584
    - Research Site
  - Valparaiso, Chile, 2341131
    - Research Site
  - Viña del Mar, Chile, 2520024
    - Research Site
China
- - Baotou, China, 14010
    - Research Site
  - Beijing, China, 100020
    - Research Site
  - Beijing, China, 100034
    - Research Site
  - Beijing, China, 100050
    - Research Site
  - Beijing, China, CN-100029
    - Research Site
  - Changsha, China, 410004
    - Research Site
  - Changsha, China, 410005
    - Research Site
  - Changsha, China, 410078
    - Research Site
  - Chengdu, China, 610041
    - Research Site
  - Guangzhou, China, 510150
    - Research Site
  - Guangzhou, China, 510080
    - Research Site
  - Guangzhou, China, 510220
    - Research Site
  - Guiyang, China, 550004
    - Research Site
  - Haikou, China, 570208
    - Research Site
  - Hangzhou, China, 310006
    - Research Site
  - Hangzhou, China, 310003
    - Research Site
  - Hohhot, China, 010017
    - Research Site
  - Hohhot, China, 610078
    - Research Site
  - Huhehaote, China, 010050
    - Research Site
  - Lanzhou, China, 730000
    - Research Site
  - Linhai, China, 317000
    - Research Site
  - Nanchang, China, 330006
    - Research Site
  - Nanjing, China, 210006
    - Research Site
  - Nanjing, China, CN-210000
    - Research Site
  - Nanjing, China, 210000
    - Research Site
  - Pingxiang, China, 337055
    - Research Site
  - Shanghai, China, 201199
    - Research Site
  - Shanghai, China, 200135
    - Research Site
  - Shenyang, China, 110001
    - Research Site
  - Shenzhen, China, 518020
    - Research Site
  - Shenzhen, China, 518029
    - Research Site
  - Shijiazhuang, China, 050051
    - Research Site
  - Shijiazhuang, China, 50051
    - Research Site
  - Wuhan, China, 430033
    - Research Site
  - Xi'an, China, 710004
    - Research Site
  - Xiangtan, China, 411100
    - Research Site
  - Xuzhou, China, 221006
    - Research Site
  - Yanji, China, 133000
    - Research Site
  - Zhanjiang, China, 524001
    - Research Site
Czechia
- - Benešov, Czechia, 256 01
    - Research Site
  - Beroun, Czechia, 26601
    - Research Site
  - Jindrichuv Hradec, Czechia, 37701
    - Research Site
  - Liberec, Czechia, 525947
    - Research Site
  - Liberec 1, Czechia, 46063
    - Research Site
  - Melnik, Czechia, 250 63
    - Research Site
  - Moravsky Krumlov, Czechia, 67201
    - Research Site
  - Praha 1, Czechia, 110 00
    - Research Site
  - Praha 10, Czechia, 10800
    - Research Site
  - Teplice, Czechia, 415 01
    - Research Site
  - Zatec, Czechia, 43801
    - Research Site
France
- - Lyon Cedex 4, France, 69317
    - Research Site
  - Marseille, France, 13003
    - Research Site
  - Nantes, France, 44277
    - Research Site
  - Nimes Cedex 09, France, 30029
    - Research Site
  - Vandoeuvre les Nancy, France, 54500
    - Research Site
Germany
- - Aschaffenburg, Germany, 63739
    - Research Site
  - Augsburg, Germany, 86150
    - Research Site
  - Bad Wörishofen, Germany, 86825
    - Research Site
  - Bamberg, Germany, 96049
    - Research Site
  - Bergisch Gladbach, Germany, 51429
    - Research Site
  - Berlin, Germany, 14059
    - Research Site
  - Berlin, Germany, 10117
    - Research Site
  - Berlin, Germany, 10367
    - Research Site
  - Berlin, Germany, 10717
    - Research Site
  - Berlin, Germany, 10969
    - Research Site
  - Berlin, Germany, 10119
    - Research Site
  - Berlin, Germany, 10787
    - Research Site
  - Berlin, Germany, 12157
    - Research Site
  - Berlin, Germany, 12203
    - Research Site
  - Berlin, Germany, 13187
    - Research Site
  - Berlin, Germany, 12159
    - Research Site
  - Bonn, Germany, 53123
    - Research Site
  - Bonn, Germany, 53119
    - Research Site
  - Cottbus, Germany, 03044
    - Research Site
  - Darmstadt, Germany, 64283
    - Research Site
  - Deggendorf, Germany, 94469
    - Research Site
  - Deggingen, Germany, 73326
    - Research Site
  - Dortmund, Germany, 44263
    - Research Site
  - Düren, Germany, 52349
    - Research Site
  - Erlangen, Germany, 91052
    - Research Site
  - Essen, Germany, 45355
    - Research Site
  - Essen, Germany, 45359
    - Research Site
  - Frankfurt, Germany, 60596
    - Research Site
  - Frankfurt am Main, Germany, 60596
    - Research Site
  - Frankfurt am Main, Germany, 60389
    - Research Site
  - Gelsenkirchen, Germany, 45879
    - Research Site
  - Grosshansdof, Germany, 22927
    - Research Site
  - Halle, Germany, 06108
    - Research Site
  - Hamburg, Germany, 20354
    - Research Site
  - Hamburg, Germany, 22299
    - Research Site
  - Hannover, Germany, 30625
    - Research Site
  - Hannover, Germany, D-30173
    - Research Site
  - Hannover, Germany, 30167
    - Research Site
  - Ibbenbüren, Germany, 49477
    - Research Site
  - Kiel, Germany, 24105
    - Research Site
  - Koblenz, Germany, 56068
    - Research Site
  - Köln, Germany, 51069
    - Research Site
  - Landsberg, Germany, 86899
    - Research Site
  - Leipzig, Germany, 04357
    - Research Site
  - Leipzig, Germany, 04103
    - Research Site
  - Leipzig, Germany, 04207
    - Research Site
  - Leipzig, Germany, 04275
    - Research Site
  - Leipzig, Germany, 04107
    - Research Site
  - Leipzig, Germany, 04157
    - Research Site
  - Lübeck, Germany, 23552
    - Research Site
  - Magdeburg, Germany, 39120
    - Research Site
  - Mainz, Germany, 55131
    - Research Site
  - Marburg, Germany, 35037
    - Research Site
  - München, Germany, 80339
    - Research Site
  - München, Germany, 80539
    - Research Site
  - Münster, Germany, 48145
    - Research Site
  - Neu-Isenburg, Germany, 63263
    - Research Site
  - Peine, Germany, 31224
    - Research Site
  - Potsdam, Germany, 14469
    - Research Site
  - Radebeul, Germany, 01445
    - Research Site
  - Rosenheim, Germany, 83022
    - Research Site
  - Ruesselsheim, Germany, D-65428
    - Research Site
  - Rüdersdorf, Germany, 15562
    - Research Site
  - Schleswig, Germany, 24837
    - Research Site
  - Schwedt, Germany, 16303
    - Research Site
  - Wardenburg, Germany, 26203
    - Research Site
  - Weinheim, Germany, 69469
    - Research Site
  - Wiesbaden, Germany, 65189
    - Research Site
  - Wiesloch, Germany, 69168
    - Research Site
  - Witten, Germany, 58452
    - Research Site
  - Zerbst, Germany, 39261
    - Research Site
Hungary
- - Balassagyarmat, Hungary, 2660
    - Research Site
  - Budapest, Hungary, 1134
    - Research Site
  - Csorna, Hungary, 9300
    - Research Site
  - Debrecen, Hungary, H-4031
    - Research Site
  - Gödöllő, Hungary, 2100
    - Research Site
  - Kaposvár, Hungary, H-7400
    - Research Site
  - Kapuvar, Hungary, 09330
    - Research Site
  - Komarom, Hungary, 2900
    - Research Site
  - Komló, Hungary, 7300
    - Research Site
  - Miskolc, Hungary, 3529
    - Research Site
  - Nyíregyháza, Hungary, 4400
    - Research Site
  - Siófok, Hungary, 08600
    - Research Site
  - Szigetszentmiklós, Hungary, 2310
    - Research Site
  - Százhalombatta, Hungary, 2440
    - Research Site
  - Törökbálint, Hungary, 2045
    - Research Site
Italy
- - Bologna, Italy, 40138
    - Research Site
  - Foggia, Italy, 71100
    - Research Site
  - Genova, Italy, 16132
    - Research Site
  - Messina, Italy, 98125
    - Research Site
  - Milan, Italy, 20122
    - Research Site
  - Modena, Italy, 41124
    - Research Site
  - Napoli, Italy, 80131
    - Research Site
  - Palermo, Italy, 90127
    - Research Site
  - Parma, Italy, 43100
    - Research Site
  - Pisa, Italy, 56124
    - Research Site
  - Pordenone, Italy, 33170
    - Research Site
  - Roma, Italy, 00128
    - Research Site
  - Roma, Italy, 00133
    - Research Site
  - Roma, Italy, 00185
    - Research Site
  - Tradate, Italy, 21049
    - Research Site
Japan
- - Osakasayama-shi, Japan, 589-8511
    - Research Site
  - Sakaide-shi, Japan, 762-8550
    - Research Site
  - Seto-shi, Japan, 489-8642
    - Research Site
  - Shinagawa-ku, Japan, 142-8666
    - Research Site
  - Yanagawa-shi, Japan, 832-0059
    - Research Site
Mexico
- - Cuautitlan Izcalli, Mexico, 54769
    - Research Site
  - Guadalajara, Mexico, 44670
    - Research Site
  - Guadalajara, Mexico, 44100
    - Research Site
  - Mexico, Mexico, 14050
    - Research Site
  - Monterrey, Mexico, 64060
    - Research Site
  - Monterrey, Mexico, 64718
    - Research Site
Netherlands
- - Almelo, Netherlands, 7609 PP
    - Research Site
  - Almere, Netherlands, 1311 RL
    - Research Site
  - Almere, Netherlands, 3562KX
    - Research Site
  - Beek, Netherlands, 6191 JW
    - Research Site
  - Breda, Netherlands, 4818 CK
    - Research Site
  - Capelle aan den IJssel, Netherlands, 2906 ZC
    - Research Site
  - Eindhoven, Netherlands, 5623EJ
    - Research Site
  - Enschede, Netherlands, 7512 KZ
    - Research Site
  - Harderwijk, Netherlands, 3844 DG
    - Research Site
  - Heerlen, Netherlands, 6419 PC
    - Research Site
  - Hoorn NH, Netherlands, 1624 NP
    - Research Site
  - Voerendaal, Netherlands, 6367
    - Research Site
  - Zutphen, Netherlands, 7207 AE
    - Research Site
  - Zwolle, Netherlands, 8025 AB
    - Research Site
New Zealand
- - Auckland, New Zealand, 0626
    - Research Site
  - Christchurch, New Zealand, 8024
    - Research Site
  - Christchurch, New Zealand, 8140
    - Research Site
  - Dunedin, New Zealand, 9016
    - Research Site
  - Greenlane, New Zealand, 1051
    - Research Site
  - Greenlane East, New Zealand, 1051
    - Research Site
  - Hamilton, New Zealand, 3240
    - Research Site
  - Havelock North, New Zealand, 4130
    - Research Site
  - Newtown, New Zealand, 6242
    - Research Site
  - Papatoetoe, New Zealand, 2025
    - Research Site
  - Tauranga, New Zealand, 3143
    - Research Site
Peru
- - Cusco, Peru
    - Research Site
  - Lima, Peru, 15033
    - Research Site
  - Lima, Peru, LIMA 27
    - Research Site
  - Lima, Peru, LIMA 41
    - Research Site
  - Lima, Peru, Lima 18
    - Research Site
  - Lima, Peru, Lima 32
    - Research Site
  - Lima, Peru, 15102
    - Research Site
  - Lima, Peru, LIMA 21
    - Research Site
  - Lima, Peru, L 41
    - Research Site
  - Lima, Peru, Lima-33
    - Research Site
  - Miraflores, Peru, 15046
    - Research Site
  - Piura, Peru, 51
    - Research Site
  - Santa Beatriz, Peru, LIMA 14
    - Research Site
Poland
- - Białystok, Poland, 15-003
    - Research Site
  - Białystok, Poland, 15-044
    - Research Site
  - Bydgoszcz, Poland, 85-863
    - Research Site
  - Poznań, Poland, 60-823
    - Research Site
  - Ruda Śląska, Poland, 41-707
    - Research Site
  - Rzeszow, Poland, 35-301
    - Research Site
  - Rzeszów, Poland, 35-205
    - Research Site
  - Skarżysko-Kamienna, Poland, 26-110
    - Research Site
  - Szczecin, Poland, 70-111
    - Research Site
  - Tarnów, Poland, 33-100
    - Research Site
  - Warszawa, Poland, 01-518
    - Research Site
  - Wrocław, Poland, 54-239
    - Research Site
  - Zabrze, Poland, 41-807
    - Research Site
Russian Federation
- - Arkhangelsk, Russian Federation, 163001
    - Research Site
  - Ekaterinburg, Russian Federation, 620039
    - Research Site
  - Gatchina, Russian Federation, 188300
    - Research Site
  - Moscow, Russian Federation, 119991
    - Research Site
  - Moscow, Russian Federation, 125315
    - Research Site
  - Moscow, Russian Federation, 129090
    - Research Site
  - Moscow, Russian Federation, 117997
    - Research Site
  - Moscow, Russian Federation, 105229
    - Research Site
  - Moscow, Russian Federation, 115682
    - Research Site
  - Moscow, Russian Federation, 121309
    - Research Site
  - Moscow, Russian Federation, 119002
    - Research Site
  - Saint Petersburg, Russian Federation
    - Research Site
  - St. Petersburg, Russian Federation, 197022
    - Research Site
  - St. Petersburg, Russian Federation, 194356
    - Research Site
Serbia
- - Belgrade, Serbia, 11000
    - Research Site
  - Belgrade, Serbia, 11070
    - Research Site
  - Kragujevac, Serbia, 34000
    - Research Site
  - Nis, Serbia, 18000
    - Research Site
  - Sremska Kamenica, Serbia, 21204
    - Research Site
  - Valjevo, Serbia, 14000
    - Research Site
South Africa
- - Benoni, South Africa, 1500
    - Research Site
  - Bloemfontein, South Africa, 9301
    - Research Site
  - Boksburg, South Africa, 1459
    - Research Site
  - Boksburg, South Africa, 1460
    - Research Site
  - Cape Town, South Africa, 7700
    - Research Site
  - Cape Town, South Africa, 7764
    - Research Site
  - Cape Town, South Africa, 7570
    - Research Site
  - Cape Town, South Africa, 7500
    - Research Site
  - Cape Town, South Africa, 7550
    - Research Site
  - Cape Town, South Africa, 08000
    - Research Site
  - Cape Town, South Africa, 7780
    - Research Site
  - Durban, South Africa, 4001
    - Research Site
  - Durban, South Africa, 4071
    - Research Site
  - Johannesburg, South Africa, 1724
    - Research Site
  - Johannesburg, South Africa, 2188
    - Research Site
  - Port Elizabeth, South Africa, 6014
    - Research Site
  - Pretoria, South Africa, 0002
    - Research Site
  - Pretoria, South Africa, 0183
    - Research Site
  - Pretoria, South Africa, 0014
    - Research Site
  - Umhlanga, South Africa, 4319
    - Research Site
Spain
- - Alcobendas, Spain, 28100
    - Research Site
  - Alicante, Spain, 03004
    - Research Site
  - Alzira, Spain, 46410
    - Research Site
  - Badalona(Barcelona), Spain, 08916
    - Research Site
  - Barcelona, Spain, 08028
    - Research Site
  - Barcelona, Spain, 08041
    - Research Site
  - Barcelona, Spain, 08003
    - Research Site
  - Barcelona, Spain, 08006
    - Research Site
  - Barcelona, Spain, 08023
    - Research Site
  - Barcelona, Spain, 08550
    - Research Site
  - Cartagena, Spain, 30202
    - Research Site
  - Coruna, Spain, 15011A
    - Research Site
  - Girona, Spain, 17005
    - Research Site
  - Laredo, Spain, 39770
    - Research Site
  - Lleida, Spain, 25198
    - Research Site
  - Madrid, Spain, 28040
    - Research Site
  - Madrid, Spain, 28007
    - Research Site
  - Malaga, Spain, 29010
    - Research Site
  - Marbella (Málaga), Spain, 29603
    - Research Site
  - Mataro, Spain, 08303
    - Research Site
  - Mérida (Badajoz), Spain, 06800
    - Research Site
  - Pamplona, Spain, 31008
    - Research Site
  - Peralada, Spain, 17491
    - Research Site
  - Ponferrada, Spain, 24411
    - Research Site
  - Sabadell, Spain, 08208
    - Research Site
  - Salamanca, Spain, 37007
    - Research Site
  - Sant Boi de Llobregat, Spain, 08830
    - Research Site
  - Valencia, Spain, 46015
    - Research Site
  - Zaragoza, Spain, 50009
    - Research Site
Sweden
- - Helsingborg, Sweden, 25220
    - Research Site
  - Karlskrona, Sweden, 37171
    - Research Site
  - Lund, Sweden, 22222
    - Research Site
  - Malmo, Sweden, 21152
    - Research Site
  - Stockholm, Sweden, SE-181 58
    - Research Site
  - Stockholm, Sweden, 114 46
    - Research Site
Taiwan
- - Kaohsiung, Taiwan, 83301
    - Research Site
  - Kaohsiung, Taiwan, 00807
    - Research Site
  - Kaohsiung City, Taiwan, 82445
    - Research Site
  - Keelung City, Taiwan, 20401
    - Research Site
  - New-Taipei, Taiwan, 22056
    - Research Site
  - Taichung, Taiwan, 40447
    - Research Site
  - Taichung, Taiwan, 00407
    - Research Site
  - Taipei, Taiwan, 10002
    - Research Site
  - Taoyuan, Taiwan, 00333
    - Research Site
United Kingdom
- - Belfast, United Kingdom, BT7 2EB
    - Research Site
  - Birmingham, United Kingdom, B9 5SS
    - Research Site
  - Birmingham, United Kingdom, B15 2WB
    - Research Site
  - Blackpool, United Kingdom, FY3 7EN
    - Research Site
  - Blackpool, United Kingdom, FY4 3AD
    - Research Site
  - Bradford, United Kingdom, BND9 6RJ
    - Research Site
  - Chesterfield, United Kingdom, S40 4AA
    - Research Site
  - Corby, United Kingdom, NN17 2UR
    - Research Site
  - Edinburgh, United Kingdom, EH16 4SA
    - Research Site
  - Glasgow, United Kingdom, G69 7AD
    - Research Site
  - Kenilworth, United Kingdom, CV8 1JD
    - Research Site
  - Liverpool, United Kingdom, L14 3PE
    - Research Site
  - London, United Kingdom, EC1M 6BQ
    - Research Site
  - London, United Kingdom, NW3 2PF
    - Research Site
  - Middlesex, United Kingdom, HA2 2RN
    - Research Site
  - Norwich, United Kingdom, NR4 7TJ
    - Research Site
  - Peterborough, United Kingdom, PE8 6PL
    - Research Site
  - Romford, United Kingdom, RM1 3PJ
    - Research Site
  - Shipley, United Kingdom, BD18 3SA
    - Research Site
  - Sidcup, United Kingdom, DA14 6LT
    - Research Site
  - Wokingham, United Kingdom, RG40 1XS
    - Research Site
United States
- Alabama
  - Andalusia, Alabama, United States, 36420
    - Research Site
  - Athens, Alabama, United States, 35611
    - Research Site
  - Birmingham, Alabama, United States, 35209
    - Research Site
  - Birmingham, Alabama, United States, 35243
    - Research Site
  - Birmingham, Alabama, United States, 35235
    - Research Site
  - Dothan, Alabama, United States, 36303
    - Research Site
  - Florence, Alabama, United States, 35630
    - Research Site
  - Foley, Alabama, United States, 36535
    - Research Site
  - Gulf Shores, Alabama, United States, 36542
    - Research Site
  - Jasper, Alabama, United States, 35501
    - Research Site
  - Mobile, Alabama, United States, 36608
    - Research Site
  - Montgomery, Alabama, United States, 36106
    - Research Site
  - Scottsboro, Alabama, United States, 35768
    - Research Site
  - Sheffield, Alabama, United States, 35660
    - Research Site
- Arizona
  - Peoria, Arizona, United States, 85381
    - Research Site
  - Phoenix, Arizona, United States, 85018
    - Research Site
  - Phoenix, Arizona, United States, 85020
    - Research Site
  - Phoenix, Arizona, United States, 85012
    - Research Site
  - Scottsdale, Arizona, United States, 85258
    - Research Site
- Arkansas
  - Conway, Arkansas, United States, 72032
    - Research Site
  - Little Rock, Arkansas, United States, 72209
    - Research Site
  - Little Rock, Arkansas, United States, 72205
    - Research Site
  - North Little Rock, Arkansas, United States, 72117
    - Research Site
- California
  - Bakersfield, California, United States, 93301
    - Research Site
  - Beverly Hills, California, United States, 90212
    - Research Site
  - Cerritos, California, United States, 90703
    - Research Site
  - El Cajon, California, United States, 92020
    - Research Site
  - Escondido, California, United States, 92025
    - Research Site
  - Fresno, California, United States, 93702
    - Research Site
  - Gold River, California, United States, 95670
    - Research Site
  - Hawaiian Gardens, California, United States, 90716
    - Research Site
  - Huntington Beach, California, United States, 92647
    - Research Site
  - Huntington Park, California, United States, 90255-6046
    - Research Site
  - La Mirada, California, United States, 90638
    - Research Site
  - Lakewood, California, United States, 90712
    - Research Site
  - Los Angeles, California, United States, 90025
    - Research Site
  - Los Angeles, California, United States, 90017
    - Research Site
  - Los Angeles, California, United States, 90036
    - Research Site
  - Los Angeles, California, United States, 90048
    - Research Site
  - Newport Beach, California, United States, 92663
    - Research Site
  - Northridge, California, United States, 91324
    - Research Site
  - Palm Springs, California, United States, 92262
    - Research Site
  - Poway, California, United States, 92064
    - Research Site
  - Quartz Hill, California, United States, 93536
    - Research Site
  - Rancho Mirage, California, United States, 92270
    - Research Site
  - Riverside, California, United States, 92506
    - Research Site
  - Rolling Hills Estates, California, United States, 90274
    - Research Site
  - Sacramento, California, United States, 95821
    - Research Site
  - Sacramento, California, United States, 95823
    - Research Site
  - Sacramento, California, United States, 95831
    - Research Site
  - San Diego, California, United States, 92120
    - Research Site
  - San Diego, California, United States, 92117
    - Research Site
  - Santa Ana, California, United States, 92705
    - Research Site
  - Santa Ana, California, United States, 92704
    - Research Site
  - Santa Monica, California, United States, 90404
    - Research Site
  - Stockton, California, United States, 95207
    - Research Site
  - Torrance, California, United States, 90503
    - Research Site
  - Tustin, California, United States, 92780
    - Research Site
  - Upland, California, United States, 91786
    - Research Site
  - Westminster, California, United States, 92683
    - Research Site
  - Wildomar, California, United States, 92595
    - Research Site
- Colorado
  - Colorado Springs, Colorado, United States, 80922
    - Research Site
  - Colorado Springs, Colorado, United States, 80910
    - Research Site
  - Fort Collins, Colorado, United States, 80525
    - Research Site
  - Lafayette, Colorado, United States, 80026
    - Research Site
- Florida
  - Boynton Beach, Florida, United States, 33435
    - Research Site
  - Brandon, Florida, United States, 33511
    - Research Site
  - Clearwater, Florida, United States, 33765
    - Research Site
  - Clearwater, Florida, United States, 33756
    - Research Site
  - Clermont, Florida, United States, 34711
    - Research Site
  - Coral Gables, Florida, United States, 33134
    - Research Site
  - Daytona Beach, Florida, United States, 32117
    - Research Site
  - Fort Lauderdale, Florida, United States, 33308
    - Research Site
  - Gainesville, Florida, United States, 32607
    - Research Site
  - Hialeah, Florida, United States, 33012
    - Research Site
  - Hialeah, Florida, United States, 33029
    - Research Site
  - Hollywood, Florida, United States, 33024
    - Research Site
  - Homestead, Florida, United States, 33030
    - Research Site
  - Kissimmee, Florida, United States, 34741
    - Research Site
  - Kissimmee, Florida, United States, 34744
    - Research Site
  - Leesburg, Florida, United States, 34748
    - Research Site
  - Loxahatchee Groves, Florida, United States, 33470
    - Research Site
  - Miami, Florida, United States, 33126
    - Research Site
  - Miami, Florida, United States, 33186
    - Research Site
  - Miami, Florida, United States, 33165
    - Research Site
  - Miami, Florida, United States, 33175
    - Research Site
  - Miami, Florida, United States, 33144
    - Research Site
  - Miami, Florida, United States, 33125
    - Research Site
  - Miami, Florida, United States, 33155
    - Research Site
  - Miami, Florida, United States, 33174
    - Research Site
  - Miami, Florida, United States, 33012
    - Research Site
  - Miami Lakes, Florida, United States, 33014
    - Research Site
  - Ormond Beach, Florida, United States, 32174
    - Research Site
  - Panama City, Florida, United States, 32405
    - Research Site
  - Pembroke Pines, Florida, United States, 33029
    - Research Site
  - Pensacola, Florida, United States, 32503
    - Research Site
  - Port Charlotte, Florida, United States, 33952
    - Research Site
  - Saint Petersburg, Florida, United States, 33704
    - Research Site
  - Saint Petersburg, Florida, United States, 33710
    - Research Site
  - Saint Petersburg, Florida, United States, 33707
    - Research Site
  - Sarasota, Florida, United States, 34239
    - Research Site
  - Tampa, Florida, United States, 33603
    - Research Site
  - Tampa, Florida, United States, 33607
    - Research Site
  - Winter Park, Florida, United States, 32789
    - Research Site
- Georgia
  - Atlanta, Georgia, United States, 30328
    - Research Site
  - Atlanta, Georgia, United States, 30308
    - Research Site
  - Atlanta, Georgia, United States, 30345
    - Research Site
  - Atlanta, Georgia, United States, 30331
    - Research Site
  - Blue Ridge, Georgia, United States, 30513
    - Research Site
  - Columbus, Georgia, United States, 31904
    - Research Site
  - Dacula, Georgia, United States, 30019
    - Research Site
  - Duluth, Georgia, United States, 30096
    - Research Site
  - Lawrenceville, Georgia, United States, 30046
    - Research Site
  - Norcross, Georgia, United States, 30071
    - Research Site
  - Rincon, Georgia, United States, 31326
    - Research Site
  - Riverdale, Georgia, United States, 30274
    - Research Site
  - Savannah, Georgia, United States, 31406
    - Research Site
  - Woodstock, Georgia, United States, 30189
    - Research Site
- Illinois
  - Belleville, Illinois, United States, 62220
    - Research Site
  - Champaign, Illinois, United States, 61820
    - Research Site
  - Chicago, Illinois, United States, 60607
    - Research Site
  - O'Fallon, Illinois, United States, 62269
    - Research Site
  - Skokie, Illinois, United States, 60076
    - Research Site
- Indiana
  - Michigan City, Indiana, United States, 46360
    - Research Site
  - Valparaiso, Indiana, United States, 46383
    - Research Site
- Iowa
  - Council Bluffs, Iowa, United States, 51503
    - Research Site
  - West Des Moines, Iowa, United States, 50266
    - Research Site
- Kentucky
  - Fort Mitchell, Kentucky, United States, 41017
    - Research Site
  - Owensboro, Kentucky, United States, 42303
    - Research Site
  - Paducah, Kentucky, United States, 42003
    - Research Site
- Louisiana
  - Crowley, Louisiana, United States, 70526
    - Research Site
  - Lafayette, Louisiana, United States, 70508
    - Research Site
  - Lake Charles, Louisiana, United States, 70601
    - Research Site
  - New Orleans, Louisiana, United States, 70115
    - Research Site
  - Opelousas, Louisiana, United States, 70570
    - Research Site
  - Sunset, Louisiana, United States, 70584
    - Research Site
  - Zachary, Louisiana, United States, 70791
    - Research Site
- Maine
  - Bangor, Maine, United States, 04401
    - Research Site
- Maryland
  - Baltimore, Maryland, United States, 21237
    - Research Site
  - Baltimore, Maryland, United States, 21224
    - Research Site
  - Baltimore, Maryland, United States, 21236
    - Research Site
  - Columbia, Maryland, United States, 21044
    - Research Site
  - White Marsh, Maryland, United States, 21162
    - Research Site
- Massachusetts
  - Marlborough, Massachusetts, United States, 01752
    - Research Site
  - Methuen, Massachusetts, United States, 01844
    - Research Site
  - North Dartmouth, Massachusetts, United States, 02747
    - Research Site
- Michigan
  - Buckley, Michigan, United States, 49620
    - Research Site
  - Cadillac, Michigan, United States, 49601
    - Research Site
  - Canton, Michigan, United States, 48187
    - Research Site
  - Caro, Michigan, United States, 48723
    - Research Site
  - Farmington Hills, Michigan, United States, 48336
    - Research Site
  - Flint, Michigan, United States, 48504
    - Research Site
  - Port Huron, Michigan, United States, 48060
    - Research Site
  - Rochester, Michigan, United States, 48307
    - Research Site
  - Southfield, Michigan, United States, 48034
    - Research Site
  - Troy, Michigan, United States, 48085
    - Research Site
- Minnesota
  - Edina, Minnesota, United States, 55435
    - Research Site
  - Fridley, Minnesota, United States, 55432
    - Research Site
  - Minneapolis, Minnesota, United States, 55407
    - Research Site
  - Woodbury, Minnesota, United States, 55125
    - Research Site
- Mississippi
  - Biloxi, Mississippi, United States, 39531
    - Research Site
- Missouri
  - Belton, Missouri, United States, 64012
    - Research Site
  - Chesterfield, Missouri, United States, 63017
    - Research Site
  - Saint Charles, Missouri, United States, 63301
    - Research Site
  - Saint Louis, Missouri, United States, 63141
    - Research Site
  - Saint Louis, Missouri, United States, 63143
    - Research Site
- Montana
  - Billings, Montana, United States, 59102
    - Research Site
- Nebraska
  - Bellevue, Nebraska, United States, 68005
    - Research Site
  - Bellevue, Nebraska, United States, 68123
    - Research Site
- Nevada
  - Las Vegas, Nevada, United States, 89106
    - Research Site
  - Reno, Nevada, United States, 89519
    - Research Site
- New Hampshire
  - Portsmouth, New Hampshire, United States, 03801
    - Research Site
- New Jersey
  - Marlton, New Jersey, United States, 08053
    - Research Site
  - Toms River, New Jersey, United States, 08755
    - Research Site
- New York
  - Bronx, New York, United States, 10459
    - Research Site
  - Bronx, New York, United States, 10457
    - Research Site
  - Bronx, New York, United States, 10461
    - Research Site
  - Bronx, New York, United States, 10455
    - Research Site
  - Bronx, New York, United States, 10468
    - Research Site
  - Bronxville, New York, United States, 10708
    - Research Site
  - Brooklyn, New York, United States, 11229
    - Research Site
  - Jamaica, New York, United States, 11435
    - Research Site
  - New Windsor, New York, United States, 12553
    - Research Site
  - New York, New York, United States, 10016
    - Research Site
- North Carolina
  - Asheville, North Carolina, United States, 28801
    - Research Site
  - Burlington, North Carolina, United States, 27215
    - Research Site
  - Charlotte, North Carolina, United States, 28277
    - Research Site
  - Charlotte, North Carolina, United States, 28207
    - Research Site
  - Charlotte, North Carolina, United States, 28210
    - Research Site
  - Elizabeth City, North Carolina, United States, 27909
    - Research Site
  - Gastonia, North Carolina, United States, 28054
    - Research Site
  - Greensboro, North Carolina, United States, 27408
    - Research Site
  - Hendersonville, North Carolina, United States, 28739
    - Research Site
  - Hickory, North Carolina, United States, 28601
    - Research Site
  - Huntersville, North Carolina, United States, 28078
    - Research Site
  - Lenoir, North Carolina, United States, 28645
    - Research Site
  - Monroe, North Carolina, United States, 28112
    - Research Site
  - Mooresville, North Carolina, United States, 28117
    - Research Site
  - Morganton, North Carolina, United States, 28655
    - Research Site
  - Mount Airy, North Carolina, United States, 27030
    - Research Site
  - New Bern, North Carolina, United States, 28562
    - Research Site
  - Raleigh, North Carolina, United States, 27612
    - Research Site
  - Shelby, North Carolina, United States, 28150
    - Research Site
  - Whiteville, North Carolina, United States, 28472
    - Research Site
  - Wilmington, North Carolina, United States, 28401
    - Research Site
  - Winston-Salem, North Carolina, United States, 27103
    - Research Site
- North Dakota
  - Fargo, North Dakota, United States, 58104
    - Research Site
- Ohio
  - Blue Ash, Ohio, United States, 45242
    - Research Site
  - Cincinnati, Ohio, United States, 45231
    - Research Site
  - Cincinnati, Ohio, United States, 45245
    - Research Site
  - Columbus, Ohio, United States, 43123
    - Research Site
  - Dayton, Ohio, United States, 45459
    - Research Site
  - Dayton, Ohio, United States, 45419
    - Research Site
  - Dublin, Ohio, United States, 43016
    - Research Site
  - Kettering, Ohio, United States, 45429
    - Research Site
  - Maumee, Ohio, United States, 43537
    - Research Site
  - Toledo, Ohio, United States, 43617
    - Research Site
- Oklahoma
  - Edmond, Oklahoma, United States, 73034
    - Research Site
  - Oklahoma City, Oklahoma, United States, 73103
    - Research Site
  - Tulsa, Oklahoma, United States, 74136
    - Research Site
- Oregon
  - Medford, Oregon, United States, 97504
    - Research Site
  - Portland, Oregon, United States, 97202
    - Research Site
- Pennsylvania
  - Altoona, Pennsylvania, United States, 16602
    - Research Site
  - Erie, Pennsylvania, United States, 16508
    - Research Site
  - Monroeville, Pennsylvania, United States, 15665
    - Research Site
  - Philadelphia, Pennsylvania, United States, 19114
    - Research Site
  - Phoenixville, Pennsylvania, United States, 19460
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15241
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15243
    - Research Site
  - Pittsburgh, Pennsylvania, United States, 15236
    - Research Site
  - Scottdale, Pennsylvania, United States, 15683
    - Research Site
  - Uniontown, Pennsylvania, United States, 15401
    - Research Site
- Rhode Island
  - East Providence, Rhode Island, United States, 02914
    - Research Site
  - Providence, Rhode Island, United States, 02908
    - Research Site
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Research Site
  - Charleston, South Carolina, United States, 29406
    - Research Site
  - Charleston, South Carolina, United States, 29412
    - Research Site
  - Columbia, South Carolina, United States, 29201
    - Research Site
  - Easley, South Carolina, United States, 29640
    - Research Site
  - Gaffney, South Carolina, United States, 29340
    - Research Site
  - Gaffney, South Carolina, United States, 29341
    - Research Site
  - Greenville, South Carolina, United States, 29615
    - Research Site
  - Greer, South Carolina, United States, 29651
    - Research Site
  - Greer, South Carolina, United States, 29650
    - Research Site
  - Hodges, South Carolina, United States, 29653
    - Research Site
  - Indian Land, South Carolina, United States, 29707
    - Research Site
  - Lancaster, South Carolina, United States, 29720
    - Research Site
  - Mount Pleasant, South Carolina, United States, 29464
    - Research Site
  - Rock Hill, South Carolina, United States, 29732
    - Research Site
  - Seneca, South Carolina, United States, 29678
    - Research Site
  - Spartanburg, South Carolina, United States, 29303
    - Research Site
  - Spartanburg, South Carolina, United States, 29301
    - Research Site
  - Union, South Carolina, United States, 29379
    - Research Site
- South Dakota
  - Rapid City, South Dakota, United States, 57702
    - Research Site
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Research Site
  - Hendersonville, Tennessee, United States, 37075
    - Research Site
  - Johnson City, Tennessee, United States, 37601
    - Research Site
  - Knoxville, Tennessee, United States, 37912
    - Research Site
- Texas
  - Arlington, Texas, United States, 76012
    - Research Site
  - Arlington, Texas, United States, 76014
    - Research Site
  - Boerne, Texas, United States, 78006
    - Research Site
  - Carrollton, Texas, United States, 75007
    - Research Site
  - Corsicana, Texas, United States, 75110
    - Research Site
  - Cypress, Texas, United States, 77429
    - Research Site
  - Duncanville, Texas, United States, 75116
    - Research Site
  - El Paso, Texas, United States, 79903
    - Research Site
  - Fort Worth, Texas, United States, 76109
    - Research Site
  - Fort Worth, Texas, United States, 76104
    - Research Site
  - Houston, Texas, United States, 77074
    - Research Site
  - Houston, Texas, United States, 77058
    - Research Site
  - Houston, Texas, United States, 77070
    - Research Site
  - Houston, Texas, United States, 77084
    - Research Site
  - Houston, Texas, United States, 77099
    - Research Site
  - Houston, Texas, United States, 77079
    - Research Site
  - Houston, Texas, United States, 77089
    - Research Site
  - Houston, Texas, United States, 77008
    - Research Site
  - Houston, Texas, United States, 77043
    - Research Site
  - Huntsville, Texas, United States, 77340
    - Research Site
  - Katy, Texas, United States, 77450
    - Research Site
  - Kerrville, Texas, United States, 78028
    - Research Site
  - Killeen, Texas, United States, 76543
    - Research Site
  - Kingwood, Texas, United States, 77339
    - Research Site
  - Lampasas, Texas, United States, 76550
    - Research Site
  - Lewisville, Texas, United States, 75067
    - Research Site
  - Longview, Texas, United States, 75605
    - Research Site
  - Lufkin, Texas, United States, 75904
    - Research Site
  - McKinney, Texas, United States, 75069
    - Research Site
  - McKinney, Texas, United States, 75071
    - Research Site
  - Pearland, Texas, United States, 77584
    - Research Site
  - Pflugerville, Texas, United States, 78660
    - Research Site
  - Plano, Texas, United States, 75093
    - Research Site
  - San Antonio, Texas, United States, 78229
    - Research Site
  - San Antonio, Texas, United States, 78258
    - Research Site
  - Sealy, Texas, United States, 77474
    - Research Site
  - Sherman, Texas, United States, 75092
    - Research Site
  - Splendora, Texas, United States, 77372
    - Research Site
  - The Woodlands, Texas, United States, 77380
    - Research Site
  - Webster, Texas, United States, 77598
    - Research Site
- Utah
  - Midvale, Utah, United States, 84047
    - Research Site
  - Salt Lake City, Utah, United States, 84102
    - Research Site
- Virginia
  - Abingdon, Virginia, United States, 24210
    - Research Site
  - Burke, Virginia, United States, 22015
    - Research Site
  - Newport News, Virginia, United States, 23606
    - Research Site
  - Richmond, Virginia, United States, 23225
    - Research Site
  - Richmond, Virginia, United States, 23220
    - Research Site
  - Richmond, Virginia, United States, 23235
    - Research Site
  - Richmond, Virginia, United States, 23230
    - Research Site
  - Richmond, Virginia, United States, 23219
    - Research Site
  - Richmond, Virginia, United States, 23114
    - Research Site
  - Virginia Beach, Virginia, United States, 23454
    - Research Site
  - Williamsburg, Virginia, United States, 23188
    - Research Site
- Washington
  - Bellevue, Washington, United States, 98007
    - Research Site
  - Richland, Washington, United States, 99352
    - Research Site
  - Spokane, Washington, United States, 99202
    - Research Site
  - Spokane, Washington, United States, 99216
    - Research Site
  - Tacoma, Washington, United States, 98405
    - Research Site
- West Virginia
  - Morgantown, West Virginia, United States, 26505
    - Research Site
- Wisconsin
  - Greenfield, Wisconsin, United States, 53228
    - 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

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria

Non-child bearing potential (ie, physiologically incapable of becoming pregnant, including any female who is 2 years post-menopausal); or Child bearing potential, has a negative serum pregnancy test at Visit 1, and agrees to acceptable contraceptive methods used consistently and correctly for the duration of the study.
Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS),
Current or former smokers with a history of at least 10 pack-years of cigarette smoking.
Forced expiratory volume in 1 second (FEV1)/Forced vital capacity (FVC) ratio must be <0.70 and FEV1 must be <65% predicted normal value calculated using NHANES III reference equations (or reference norms applicable to other regions).
Subjects with history of exacerbations.

Please refer to the study protocol for the complete inclusion criteria list.

Exclusion Criteria

Significant diseases or conditions other than COPD, which, in the opinion of the Investigator, may put the subject at risk because of participation in the study or may influence either the results of the study or the subject's ability to participate in the study.
Women who are pregnant or lactating, or are planning to become pregnant during the course of the study, or women of childbearing potential who are not using an acceptable method of contraception.
Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma.
Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Visit 1 (Screening)
Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Visit 1 (Screening)
Immune suppression or severe neurological disorders affecting control of the upper airway or other risk factors that in the opinion of the Investigator would put the subject at substantial risk of pneumonia.
Subjects with a diagnosis of narrow angle glaucoma, who, in the opinion of the Investigator, have not been adequately treated.
Subjects who have a history of hypersensitivity to β2-agonists, budesonide or any other corticosteroid components, glycopyrronium or other muscarinic anticholinergics, or any other component of the IMPs.

Please refer to the study protocol for the complete inclusion criteria list.

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 (PT010) MDI 320/14.4/9.6 μg BGF MDI 320/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])	Drug: BGF MDI 320/14.4/9.6 μg Budensonide, Glycopyrronium, and Formoterol Fumarate Other Names: BGF
Experimental: BGF (PT010) MDI 160/14.4/9.6 μg BGF MDI 160/14.4/9.6 μg, Budesonide, Glycopyrronium, Formoterol Fumarate Aerosol (PT010, BGF metered dose inhaler [MDI])	Drug: BGF MDI 160/14.4/9.6 μg Budensonide, Glycopyrronium, and Formoterol Fumarate Other Names: BGF
Experimental: BFF (PT009) MDI 320/9.6 μg BFF MDI 320/9.6 μg Budesonide, Formoterol Fumarate Aerosol Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT009)	Drug: BFF MDI 320/9.6 μg Budensonide, and Formoterol Fumarate Other Names: BFF
Experimental: GFF (PT003) MDI 14.4/9.6 μg GFF MDI 14.4/9.6 μg Glycopyrronium, Formoterol Fumarate Aerosol Budesonide and Formoterol Fumarate Inhalation Aerosol (PT003)	Drug: GFF MDI 14.4/9.6 μg Glycopyrronium, and Formoterol Fumarate Other Names: GFF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adjusted Rate of Moderate or Severe Exacerbations Time Frame: 52-week treatment period	Adjusted Rate of Moderate or Severe Exacerbations	52-week treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to First Moderate or Severe COPD Exacerbation Time Frame: 52 Weeks	Time to first moderate or severe COPD exacerbation (proportion with event reported as median time was not reached, statistical analyses are based upon time to event)	52 Weeks
Change From Baseline in Average Daily Rescue Ventolin HFA Use Over 24 Weeks Time Frame: 24 Weeks	Change from baseline in average daily rescue Ventolin HFA use over 24 weeks	24 Weeks
Percentage of Subjects Achieving a MCID of 4 Units or More in SGRQ Total Score Time Frame: at Week 24	Percentage of subjects achieving a minimal clinically important difference (MCID) of 4 units or more in SGRQ (St. George's Respiratory Questionnaire) total score at Week 24	at Week 24
Time to Death (All Cause) Time Frame: 52 Weeks	Subject Deaths (all cause)	52 Weeks
Rate of Severe COPD Exacerbations Time Frame: 52 Weeks	Rate of severe COPD exacerbations	52 Weeks

Collaborators and Investigators

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

Sponsor

Pearl Therapeutics, Inc.

Investigators

Study Director: Paul M Dorinsky, MD, Pearl Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Actual)

July 26, 2019

Study Completion (Actual)

July 26, 2019

Study Registration Dates

First Submitted

May 29, 2015

First Submitted That Met QC Criteria

June 5, 2015

First Posted (Estimate)

June 8, 2015

Study Record Updates

Last Update Posted (Actual)

February 2, 2021

Last Update Submitted That Met QC Criteria

February 1, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

PT010005

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 (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

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

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

General Publications

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Other Study ID Numbers

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

Clinical Trials on BGF MDI 320/14.4/9.6 μg

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