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PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PH-797804 | Experimental | PH-797804 at four dose levels |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PH-797804 | Drug | PH-797804 at four dose levels |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. | 6 weeks | |
| Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Peak expiratory flow rate. | 6 weeks | |
| Blood sample for pharmacogenomics | 6 weeks | |
| Blood sample for pharmacokinetics |
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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 | La Plata | Buenos Aires | 1900 | Argentina | ||
| Pfizer Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23539534 | Derived | MacNee W, Allan RJ, Jones I, De Salvo MC, Tan LF. Efficacy and safety of the oral p38 inhibitor PH-797804 in chronic obstructive pulmonary disease: a randomised clinical trial. Thorax. 2013 Aug;68(8):738-45. doi: 10.1136/thoraxjnl-2012-202744. Epub 2013 Mar 28. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| Drug |
Placebo |
|
| 6 weeks |
| Rescue bronchodilator usage. | 6 weeks |
| Dyspnea index scores. | 6 weeks |
| Global impression of change (patient and clinician). | 6 weeks |
| Symptom scores. | 6 weeks |
| Blood sample for biomarkers | 6 weeks |
| Buenos Aires |
| Buenos Aires F.D. |
| C1425DQI |
| Argentina |
| Pfizer Investigational Site | Buenos Aires | Buenos Aires F.D. | C1426ABP | Argentina |
| Pfizer Investigational Site | Ciudad Autonoma de Buenos Aires (caba) | Buenos Aires F.D. | C1428DDE | Argentina |
| Pfizer Investigational Site | Rosario | Santa Fe Province | 2000 | Argentina |
| Pfizer Investigational Site | Camperdown | New South Wales | 2050 | Australia |
| Pfizer Investigational Site | Daw Park | South Australia | 5041 | Australia |
| Pfizer Investigational Site | Nedlands | Western Australia | 6009 | Australia |
| Pfizer Investigational Site | Vancouver | British Columbia | V5Z 4E1 | Canada |
| Pfizer Investigational Site | Winnipeg | Manitoba | R2K 3S8 | Canada |
| Pfizer Investigational Site | Hamilton | Ontario | L8N 3Z5 | Canada |
| Pfizer Investigational Site | Kingston | Ontario | K7L 2V7 | Canada |
| Pfizer Investigational Site | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Pfizer Investigational Site | Providencia | Santiago, RM | 7500691 | Chile |
| Pfizer Investigational Site | Valparaíso | Valparaiso | 2352499 | Chile |
| Pfizer Investigational Site | Talca | 3460001 | Chile |
| Pfizer Investigational Site | Cvikov | 471 54 | Czechia |
| Pfizer Investigational Site | Kutná Hora | 283 01 | Czechia |
| Pfizer Investigational Site | Liberec | 460 01 | Czechia |
| Pfizer Investigational Site | Prague | 153 00 | Czechia |
| Pfizer Investigational Site | Strakonice | 387 01 | Czechia |
| Pfizer Investigational Site | Tábor | 39001 | Czechia |
| Pfizer Investigational Site | Lille | 59042 CEDEX | France |
| Pfizer Investigational Site | Marseille | 13009 | France |
| Pfizer Investigational Site | Montpellier | 34295 CEDEX 5 | France |
| Pfizer Investigational Site | Perpignan | 66000 | France |
| Pfizer Investigational Site | Athens | 10676 | Greece |
| Pfizer Investigational Site | Heraklion | 711 10 | Greece |
| Pfizer Investigational Site | Larissa | 41 110 | Greece |
| Pfizer Investigational Site | Budapest | 1125 | Hungary |
| Pfizer Investigational Site | Budapest | H-1036 | Hungary |
| Pfizer Investigational Site | Deszk | 6772 | Hungary |
| Pfizer Investigational Site | Pécs | 7626 | Hungary |
| Pfizer Investigational Site | Szombathely | 9700 | Hungary |
| Pfizer Investigational Site | Almere Stad | 1311 RL | Netherlands |
| Pfizer Investigational Site | Zutphen | 7207 BA | Netherlands |
| Pfizer Investigational Site | Yaroslavl | 150003 | Russia |
| Pfizer Investigational Site | Yaroslavl | 150023 | Russia |
| Pfizer Investigational Site | Durban | KwaZulu-Natal | 4001 | South Africa |
| Pfizer Investigational Site | Bloemfontein | 9301 | South Africa |
| Pfizer Investigational Site | Durban | 4126 | South Africa |
| Pfizer Investigational Site | Anyang | 431-070 | South Korea |
| Pfizer Investigational Site | Seoul | 135-710 | South Korea |
| Pfizer Investigational Site | Seoul | 138-736 | South Korea |
| Pfizer Investigational Site | Edinburgh | EH16 4SA | United Kingdom |
| 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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