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

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Fluticasone; Salmeterol Xinafoate

Criteria

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.