A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00559910 |
Recruitment Status :
Completed
First Posted : November 16, 2007
Last Update Posted : October 16, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Chronic Obstructive Pulmonary Disease | Drug: PH-797804 Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 230 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase II, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of Once-Daily Orally Administered PH-797804 (0.5, 3, 6 And 10 MG) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD). |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | December 2009 |
Actual Study Completion Date : | December 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: PH-797804
PH-797804 at four dose levels
|
Drug: PH-797804
PH-797804 at four dose levels |
Placebo Comparator: Placebo
Placebo
|
Drug: Placebo
Placebo |
- Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]
- Spirometry measures during 6 weeks of treatment and up to 2 weeks post treatment. [ Time Frame: 6 weeks ]
- Peak expiratory flow rate. [ Time Frame: 6 weeks ]
- Blood sample for pharmacogenomics [ Time Frame: 6 weeks ]
- Blood sample for pharmacokinetics [ Time Frame: 6 weeks ]
- Rescue bronchodilator usage. [ Time Frame: 6 weeks ]
- Dyspnea index scores. [ Time Frame: 6 weeks ]
- Global impression of change (patient and clinician). [ Time Frame: 6 weeks ]
- Symptom scores. [ Time Frame: 6 weeks ]
- Blood sample for biomarkers [ Time Frame: 6 weeks ]

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Ages Eligible for Study: | 40 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female subjects between, and including, the ages of 40 and 80 years.
- Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening.
- Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
Exclusion Criteria:
- More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
- History or presence of significant cardiovascular disease.
- ECG abnormalities.
- Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
- Evidence of organ or blood disorders.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00559910
Argentina | |
Pfizer Investigational Site | |
La Plata, Buenos Aires, Argentina, 1900 | |
Pfizer Investigational Site | |
Buenos Aires, Capital Federal, Argentina, C1425DQI | |
Pfizer Investigational Site | |
Buenos Aires, Capital Federal, Argentina, C1426ABP | |
Pfizer Investigational Site | |
Ciudad Autonoma de Buenos Aires (CABA), Capital Federal, Argentina, C1428DDE | |
Pfizer Investigational Site | |
Rosario, Santa Fe, Argentina, 2000 | |
Australia, New South Wales | |
Pfizer Investigational Site | |
Camperdown, New South Wales, Australia, 2050 | |
Australia, South Australia | |
Pfizer Investigational Site | |
Daw Park, South Australia, Australia, 5041 | |
Australia, Western Australia | |
Pfizer Investigational Site | |
Nedlands, Western Australia, Australia, 6009 | |
Canada, British Columbia | |
Pfizer Investigational Site | |
Vancouver, British Columbia, Canada, V5Z 4E1 | |
Canada, Manitoba | |
Pfizer Investigational Site | |
Winnipeg, Manitoba, Canada, R2K 3S8 | |
Canada, Ontario | |
Pfizer Investigational Site | |
Hamilton, Ontario, Canada, L8N 3Z5 | |
Pfizer Investigational Site | |
Kingston, Ontario, Canada, K7L 2V7 | |
Canada, Quebec | |
Pfizer Investigational Site | |
Sainte-Foy, Quebec, Canada, G1V 4G5 | |
Chile | |
Pfizer Investigational Site | |
Providencia, Santiago, RM, Chile, 7500691 | |
Pfizer Investigational Site | |
Valparaiso, V Región, Chile, 2352499 | |
Pfizer Investigational Site | |
Talca, Chile, 3460001 | |
Czechia | |
Pfizer Investigational Site | |
Cvikov, Czechia, 471 54 | |
Pfizer Investigational Site | |
Kutna Hora, Czechia, 283 01 | |
Pfizer Investigational Site | |
Liberec, Czechia, 460 01 | |
Pfizer Investigational Site | |
Praha 5, Czechia, 153 00 | |
Pfizer Investigational Site | |
Strakonice, Czechia, 387 01 | |
Pfizer Investigational Site | |
Tabor, Czechia, 39001 | |
France | |
Pfizer Investigational Site | |
Lille, France, 59042 CEDEX | |
Pfizer Investigational Site | |
Marseille, France, 13009 | |
Pfizer Investigational Site | |
Montpellier, France, 34295 CEDEX 5 | |
Pfizer Investigational Site | |
Perpignan, France, 66000 | |
Greece | |
Pfizer Investigational Site | |
Athens, Greece, 10676 | |
Pfizer Investigational Site | |
Heraklion, Greece, 711 10 | |
Pfizer Investigational Site | |
Larissa, Greece, 41 110 | |
Hungary | |
Pfizer Investigational Site | |
Budapest, Hungary, 1125 | |
Pfizer Investigational Site | |
Budapest, Hungary, H-1036 | |
Pfizer Investigational Site | |
Deszk, Hungary, 6772 | |
Pfizer Investigational Site | |
Pecs, Hungary, 7626 | |
Pfizer Investigational Site | |
Szombathely, Hungary, 9700 | |
Korea, Republic of | |
Pfizer Investigational Site | |
Anyang, Korea, Republic of, 431-070 | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 135-710 | |
Pfizer Investigational Site | |
Seoul, Korea, Republic of, 138-736 | |
Netherlands | |
Pfizer Investigational Site | |
Almere, Netherlands, 1311 RL | |
Pfizer Investigational Site | |
Zutphen, Netherlands, 7207 BA | |
Russian Federation | |
Pfizer Investigational Site | |
Yaroslavl, Russian Federation, 150003 | |
Pfizer Investigational Site | |
Yaroslavl, Russian Federation, 150023 | |
South Africa | |
Pfizer Investigational Site | |
Durban, Kwa-Zulu Natal, South Africa, 4001 | |
Pfizer Investigational Site | |
Bloemfontein, South Africa, 9301 | |
Pfizer Investigational Site | |
Durban, South Africa, 4126 | |
United Kingdom | |
Pfizer Investigational Site | |
Edinburgh, United Kingdom, EH16 4SA |
Study Director: | Pfizer CT.gov Call Center | Pfizer |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Director, Clinical Trial Disclosure Group, Pfizer, Inc. |
ClinicalTrials.gov Identifier: | NCT00559910 |
Other Study ID Numbers: |
A6631011 |
First Posted: | November 16, 2007 Key Record Dates |
Last Update Posted: | October 16, 2018 |
Last Verified: | October 2018 |
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases |