A phase III, 52 week, randomized, double-blind, 3-arm parallel group study, comparing the efficacy, safety and tolerability of the fixed dose triple combination FF/UMEC/VI with the fixed dose dual combinations of FF/VI and UMEC/VI, all administered once-daily in the morning via a dry powder inhaler in subjects with chronic obstructive pulmonary disease
- Conditions
- COPDchronic obstructive pulmonary disease10038716
- Registration Number
- NL-OMON45240
- Lead Sponsor
- GlaxoSmithKline
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 225
* COPD patients *40 years of age.
* (Ex) smokers, at least 10 pack years.
* Post salbutamol FEV1/FVC ratio <0,70.
* A score of *10 on the COPD Assessment Test (CAT).
* Post-bronchodilator FEV1 < 50% predicted normal and a documented history of * 1 moderate or severe COPD exacerbation in the previous 12 months OR a post-bronchodilator 50% *FEV1 < 80% predicted normal and a documented history of * 2 moderate exacerbations or a documented history of *1 severe COPD exacerbation (hospitalized) in the previous 12 months.
* Safe contraception for women of childbearing potential.
* Pregnancy, lactation.
* Risk factors for pneumonia (see protocol page 33 for details).
* Abnormal Chest x-ray (see protocol page 33 for details).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Rate of exacerbations.</p><br>
- Secondary Outcome Measures
Name Time Method <p>FEV1, St George questionnaire, time to first exacerbation. Adverse events.</p><br>