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PH-797804 is an oral anti-inflammatory drug that may reduce the inflammation that is associated with Chronic Obstructive Pulmonary Disease (COPD). PH-797804 will be dosed to patients with Chronic Obstructive Pulmonary Disease (COPD) to evaluate its potential safety and efficacy profile in Chronic Obstructive Pulmonary Disease (COPD)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PH-787904 (arm1) | Experimental |
| |
| PH-787904 (arm2) | Experimental |
| |
| PH-787904 (arm3) | Experimental |
| |
| PH-787904 (arm4) | Experimental |
| |
| PH-787904 (arm5) | Experimental |
| |
| Placebo | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH-797804 | Drug | 0.25 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough (pre-treatment and pre-bronchodilator) Forced Expiratory Volume1 at Week 12. | Baseline, week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume1 at Weeks 2, 6, and 10 | Baseline, week 2, 6, and 10 | |
| Change from baseline in trough, pre-bronchodilator Forced Expiratory Volume6 at Weeks 2, 6, 10 and 12 | Baseline, week 2, 6, 10 and 12 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Birmingham | Alabama | 35205 | United States | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| PH-797804 | Drug | 1 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| PH-797804 | Drug | 3 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| PH-797804 | Drug | 6 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| PH-797804 | Drug | 10 mg oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| Placebo | Drug | Placebo oral tablet plus tiotropium bromide 18 microgram once daily for 12 weeks |
|
| Change from baseline in trough, pre-bronchodilator Forced Vital Capacity at Weeks 2, 6, 10 and 12 | Baseline, week 2, 6, 10 and 12 |
| Change from baseline in trough, pre-bronchodilator Inspiratory Capacity at Weeks 2, 6, 10 and 12 | Baseline, week 2, 6, 10 and 12 |
| Average change from baseline in trough, pre-bronchodilator Forced Expiratory Volume 1, Forced Expiratory Volume 6, Forced Vital Capacity and Inspiratory Capacity over 12 weeks treatment | Baseline, week 12 |
| Change from baseline in post-study drug, pre-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12 | Baseline, week 0, 12 |
| Change from baseline in post-study drug, post-bronchodilator Forced Expiratory Volume1, Forced Expiratory Volume6, Forced Vital Capacity and Inspiratory Capacity at Weeks 0 and 12 | Baseline, week 0, week 12 |
| Change from baseline in Chronic Obstructive Pulmonary Disease symptoms (EXACT-PRO Daily Diary) over 12 weeks treatment. | Baseline, week 12 |
| Change from baseline in Chronic Respiratory Questionnaire - Self Administered Standard (CRQ-SAS) at Weeks 2, 6, 10 and 12 | Baseline, week 2, 4, 6, 10 and 12 |
| Patient Global Impression of Change at Week 12 | Baseline, week 12 |
| Change from baseline (Baseline Dyspnea Index) in dyspnea (Transition Dyspnea Index) at Weeks 2, 6, 10 and 12 | Baseline, week 2, 4, 6, 10, and 12 |
| Clinician Global Impression of Change at Week 12 | Baseline, week 12 |
| Rescue bronchodilator use (per daily diary) over 12 weeks of therapy | Baseline, week 12 |
| Birmingham |
| Alabama |
| 35233 |
| United States |
| Pfizer Investigational Site | Birmingham | Alabama | 35294 | United States |
| Pfizer Investigational Site | Jasper | Alabama | 35501 | United States |
| Pfizer Investigational Site | Phoenix | Arizona | 85006 | United States |
| Pfizer Investigational Site | Montclair | California | 91763 | United States |
| Pfizer Investigational Site | San Diego | California | 92120 | United States |
| Pfizer Investigational Site | Waterbury | Connecticut | 06708 | United States |
| Pfizer Investigational Site | Newark | Delaware | 19713 | United States |
| Pfizer Investigational Site | Brandon | Florida | 33511 | United States |
| Pfizer Investigational Site | Chiefland | Florida | 32226 | United States |
| Pfizer Investigational Site | Chiefland | Florida | 32626 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33756 | United States |
| Pfizer Investigational Site | Clearwater | Florida | 33765 | United States |
| Pfizer Investigational Site | New Port Richey | Florida | 34653 | United States |
| Pfizer Investigational Site | Pensacola | Florida | 32504 | United States |
| Pfizer Investigational Site | Tampa | Florida | 33603 | United States |
| Pfizer Investigational Site | Williston | Florida | 32696 | United States |
| Pfizer Investigational Site | Duluth | Georgia | 30096 | United States |
| Pfizer Investigational Site | Fort Mitchell | Kentucky | 41017 | United States |
| Pfizer Investigational Site | Lexington | Kentucky | 40504 | United States |
| Pfizer Investigational Site | Baltimore | Maryland | 21224 | United States |
| Pfizer Investigational Site | Edina | Minnesota | 55435 | United States |
| Pfizer Investigational Site | Fridley | Minnesota | 55432 | United States |
| Pfizer Investigational Site | Minneapolis | Minnesota | 55407 | United States |
| Pfizer Investigational Site | Rochester | Minnesota | 55905 | United States |
| Pfizer Investigational Site | St Louis | Missouri | 63141 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87108 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87109 | United States |
| Pfizer Investigational Site | Albuquerque | New Mexico | 87110 | United States |
| Pfizer Investigational Site | Rochester | New York | 14618 | United States |
| Pfizer Investigational Site | Charlotte | North Carolina | 28207 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45231 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45242 | United States |
| Pfizer Investigational Site | Cincinnati | Ohio | 45245 | United States |
| Pfizer Investigational Site | Oklahoma City | Oklahoma | 73112 | United States |
| Pfizer Investigational Site | Philadelphia | Pennsylvania | 19140 | United States |
| Pfizer Investigational Site | Pawtucket | Rhode Island | 02860 | United States |
| Pfizer Investigational Site | Warwick | Rhode Island | 02886 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29407 | United States |
| Pfizer Investigational Site | Charleston | South Carolina | 29414 | United States |
| Pfizer Investigational Site | Kingsport | Tennessee | 37660 | United States |
| Pfizer Investigational Site | Houston | Texas | 77030 | United States |
| Pfizer Investigational Site | San Antonio | Texas | 78212 | United States |
| Pfizer Investigational Site | Midvale | Utah | 84047 | United States |
| Pfizer Investigational Site | Buenos Aires | 1426 | Argentina |
| Pfizer Investigational Site | Rousse | 7002 | Bulgaria |
| Pfizer Investigational Site | Sevlievo | 5400 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1000 | Bulgaria |
| Pfizer Investigational Site | Sofia | 1431 | Bulgaria |
| Pfizer Investigational Site | Stara Zagora | 6003 | Bulgaria |
| Pfizer Investigational Site | Troyan Municipality | 5600 | Bulgaria |
| Pfizer Investigational Site | Veliko Tarnovo | 5000 | Bulgaria |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2K 3S8 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M5T 3A9 | Canada |
| Pfizer Investigational Site | Toronto | Ontario | M6H 3M2 | Canada |
| Pfizer Investigational Site | Montreal | Quebec | H4N 3C5 | Canada |
| Pfizer Investigational Site | Québec | Quebec | G3K 2P8 | Canada |
| Pfizer Investigational Site | Saint Romuald | Quebec | G6W 5M6 | Canada |
| Pfizer Investigational Site | Sherbrooke | Quebec | J1H 1Z1 | Canada |
| Pfizer Investigational Site | Karlovy Vary | 36009 | Czechia |
| Pfizer Investigational Site | Liberec | 460 01 | Czechia |
| Pfizer Investigational Site | Mělník | 27601 | Czechia |
| Pfizer Investigational Site | Prague | 108 00 | Czechia |
| Pfizer Investigational Site | Prague | 153 00 | Czechia |
| Pfizer Investigational Site | Rokycany | 337 22 | Czechia |
| Pfizer Investigational Site | Teplice | 41501 | Czechia |
| Pfizer Investigational Site | Berlin | 10117 | Germany |
| Pfizer Investigational Site | Berlin | 13125 | Germany |
| Pfizer Investigational Site | Dresden | 01069 | Germany |
| Pfizer Investigational Site | Gelnhausen | 63571 | Germany |
| Pfizer Investigational Site | Großhansdorf | 22927 | Germany |
| Pfizer Investigational Site | Hamburg | 20253 | Germany |
| Pfizer Investigational Site | Hamburg | 20354 | Germany |
| Pfizer Investigational Site | Hanover | 30159 | Germany |
| Pfizer Investigational Site | Kassel | 34121 | Germany |
| Pfizer Investigational Site | Lübeck | 23552 | Germany |
| Pfizer Investigational Site | Schwerin | 19055 | Germany |
| Pfizer Investigational Site | Balassagyarmat | 2660 | Hungary |
| Pfizer Investigational Site | Budaörs | 2040 | Hungary |
| Pfizer Investigational Site | Budapest | 1122 | Hungary |
| Pfizer Investigational Site | Debrecen | 4032 | Hungary |
| Pfizer Investigational Site | Szeged | 6722 | Hungary |
| Pfizer Investigational Site | Szombathely | 9700 | Hungary |
| Pfizer Investigational Site | Törökbálint | 2045 | Hungary |
| Pfizer Investigational Site | Nagoya | Aichi-ken | Japan |
| Pfizer Investigational Site | Seto-shi | Aichi-ken | Japan |
| Pfizer Investigational Site | Toyota | Aichi-ken | Japan |
| Pfizer Investigational Site | Noda | Chiba | Japan |
| Pfizer Investigational Site | Fukuoka | Fukuoka | Japan |
| Pfizer Investigational Site | Yanagawa | Fukuoka | Japan |
| Pfizer Investigational Site | Kanazawa | Ishikawa-ken | Japan |
| Pfizer Investigational Site | Takamatsu | Kagawa-ken | Japan |
| Pfizer Investigational Site | Kawasaki-shi | Kanagawa | Japan |
| Pfizer Investigational Site | Zama | Kanagawa | Japan |
| Pfizer Investigational Site | Kumamoto | Kumamoto | Japan |
| Pfizer Investigational Site | Saiki | Oita Prefecture | Japan |
| Pfizer Investigational Site | Osaka | Osaka | Japan |
| Pfizer Investigational Site | Meguro-ku | Tokyo | Japan |
| Pfizer Investigational Site | Setagaya City | Tokyo | Japan |
| Pfizer Investigational Site | Warsaw | 04-141 | Poland |
| Pfizer Investigational Site | Wroclaw | 53-301 | Poland |
| Pfizer Investigational Site | Wroclaw | 54-239 | Poland |
| Pfizer Investigational Site | Bardejov | 085 01 | Slovakia |
| Pfizer Investigational Site | Bojnice | 972 01 | Slovakia |
| Pfizer Investigational Site | Bratislava | 826 06 | Slovakia |
| Pfizer Investigational Site | Bratislava | 841 04 | Slovakia |
| Pfizer Investigational Site | Humenné | 066 01 | Slovakia |
| Pfizer Investigational Site | Košice | 040 01 | Slovakia |
| Pfizer Investigational Site | Liptovský Hrádok | 033 01 | Slovakia |
| Pfizer Investigational Site | Námestovo | 029 01 | Slovakia |
| Pfizer Investigational Site | Poprad | 058 01 | Slovakia |
| Pfizer Investigational Site | Spišská Nová Ves | 052 01 | Slovakia |
| Pfizer Investigational Site | Štúrovo | 943 01 | Slovakia |
| Pfizer Investigational Site | Bloemfontein | Free State | 9301 | South Africa |
| Pfizer Investigational Site | Gatesville | Western Cape | 7764 | South Africa |
| Pfizer Investigational Site | Parow | Western Cape | 7505 | South Africa |
| Pfizer Investigational Site | Cape Town | 7500 | South Africa |
| Pfizer Investigational Site | Cape Town | 7530 | South Africa |
| Pfizer Investigational Site | Durban | 4001 | South Africa |
| Pfizer Investigational Site | Durban | 4126 | South Africa |
| Pfizer Investigational Site | Pretoria | 0181 | South Africa |
| Pfizer Investigational Site | Petrel | Alicante | 03610 | Spain |
| Pfizer Investigational Site | Mérida | Badajoz | 06800 | Spain |
| Pfizer Investigational Site | Salt | Girona | 17190 | Spain |
| Pfizer Investigational Site | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Pfizer Investigational Site | Gothenburg | 412 63 | Sweden |
| Pfizer Investigational Site | Linköping | 58216 | Sweden |
| Pfizer Investigational Site | Lund | 22185 | Sweden |
| Pfizer Investigational Site | Malmö | 211 52 | Sweden |
| Pfizer Investigational Site | Skene | 511 62 | Sweden |
| Pfizer Investigational Site | Taipei | 100 | Taiwan |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C542398 | PH 797804 |
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