A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Pfizer

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: PH-797804

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT00559910

A6631011

Details and patient eligibility

About

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.

Enrollment

230 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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.