Study To Evaluate The Efficacy And Safety Of PH-797804 For 12 Weeks In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD) Taking Salmeterol Xinafoate/Fluticasone Propionate Combination

Pfizer

Status and phase

Completed

Phase 2

Conditions

Pulmonary Disease, Chronic Obstructive

Treatments

Drug: Placebo

Drug: PH-797804

Study type

Interventional

Funder types

Industry

Identifiers

NCT01321463

A6631029

Details and patient eligibility

About

PH-797804 is an oral 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

377 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 a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up > 6 months ago.
Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.

Exclusion criteria

A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
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.