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 Combinatio
- Conditions
- Health Condition 1: null- Pulmonary Disease, Chronic Obstructive
- Registration Number
- CTRI/2011/12/002226
- Lead Sponsor
- Pfizer Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 328
1.Male or female subjects between, and including, the ages of 40 and 80 years.
2.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.
3.Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up greater than 6 months ago.
4.Subjects must be treated with a LABA/ICS combination for at least 1 month prior to screening.
1.A COPD exacerbation requiring treatment with oral steroids or hospitalization for the treatment of COPD within 3 months of screening.
2.History or presence of significant cardiovascular disease.
3.ECG abnormalities.
4.Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
5.Evidence of organ or blood disorders.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.Spirometry measures during 12 weeks of treatment and up to 2 weeks post treatment.Timepoint: 12 weeks
- Secondary Outcome Measures
Name Time Method 1.Safety and tolerability measures (AEs, 12-lead ECG, lab safety) during 12 weeks of treatment and up to 2 weeks post treatment.Timepoint: 12 weeks;2.Dyspnea index scoresTimepoint: 12 weeks;3.Rescue bronchodilator usageTimepoint: 12 Weeks;4.Symptom scores.Timepoint: 12 weeks;5.Global impression of change (patient and clinician).Timepoint: 12 weeks;6.Blood sample for pharmacokinetics.Timepoint: 12 weeks;7.Blood and urine sample for biomarkers and molecular profiling.Timepoint: 12 weeks