DB2116134: A randomized, multi-center, double-blind, double-dummy, parallel group study to evaluate the efficacy and safety of umeclidinium/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD
Phase 3
Completed
- Conditions
- COPD10038716
- Registration Number
- NL-OMON38572
- Lead Sponsor
- GlaxoSmithKline BV
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 65
Inclusion Criteria
* COPD patients *40 years of age (see protocol page 23 for details).
* (Ex) smokers, at least 10 pack years.
* Pre and post salbutamol FEV1/FVC ratio <70%.
* Post salbutamol FEV1 *30% and *70% of predicted.
* A score of at least 2 on the Modified Medical Research Council Dyspnea Scale.
* Safe contraception for women of childbearing potential.
Exclusion Criteria
* Pregnancy.
* Bronchial asthma.
* Documented COPD exacerbation in the past 12 months.
* Hospitalization for COPD or pneumonia in the past 12 weeks.
* Significant ECG abnormalities (see protocol page 24 for details).
* Treatment with specified (mainly COPD) therapies within a specified time frame (see protocol page 24-25 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>24-hour weighted-mean FEV1 on Treatment Day 84.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Trough FEV1 on day 85, adverse events.</p><br>