A 24-Week, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of GSK573719/GW642444 Inhalation Powder and the Individual Components Delivered Once-Daily via a Novel Dry Powder Inhaler in Subjects with Chronic Obstructive Pulmonary Disease (DB2113361)
Phase 3
Completed
- Conditions
- COPD10038716
- Registration Number
- NL-OMON36160
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
• COPD patients >=40 years of age.
• (Ex) smokers, at least 10 pack years.
• Post salbutamol FEV1/FVC ratio <70%.
• Post salbutamol FEV1 <=70% of predicted.
• A score of >=2 on the Modified Medical Research Council Dyspnea Scale at Visit 1.
• Safe contraception for women of childbearing potential.
Exclusion Criteria
• Pregnancy.
• Bronchial asthma.
• Oral steroids in the past 6 weeks.
• Hospitalization for COPD or pneumonia in the past 12 weeks.
• Significant ECG abnormalities (see protocol for details).
• Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol for details).
• Previous use of GSK573719, GW642444, the GSK573719/GW642444 combination or the Fluticasone Furoate/GW642444 combination.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Change from baseline in trough FEV1 on Day 169.</p><br>
- Secondary Outcome Measures
Name Time Method <p>PK, PK-PD.</p><br>