Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
Phase 3
Completed
- Conditions
- Chronic Obstructive Pulmonary DiseaseCOPD
- Registration Number
- NCT00430729
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to investigate the effect of 500mcg roflumilast vs placebo on exacerbation rate and pulmonary function as well as quality of life in patients with chronic obstructive pulmonary disease (COPD).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1100
Inclusion Criteria
- FEV1/FVC ratio (post-bronchodilator) ≤70%
- FEV1 (post-bronchodilator) ≤50% of predicted
- Current smoker or ex-smoker
- Clinically stable COPD indicated by no exacerbation and no change in COPD treatment of within 4 weeks prior to baseline
- Availability of a chest x-ray dated a maximum of 6 months prior to study baseline visit B0 or a willingness to have a chest x-ray performed before baseline
Main
Exclusion Criteria
- COPD exacerbation indicated by a treatment with systemic glucocorticoids not stopped 4 weeks prior to baseline
- Lower respiratory tract infection not resolved 4 weeks prior to baseline
- Diagnosis of asthma and/or other relevant lung disease
- Known alpha-1-antitrypsin deficiency
- Need for long-term oxygen therapy defined as ≥16 hours/day
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period. Change in FEV1 from baseline during the treatment period.
- Secondary Outcome Measures
Name Time Method Pulmonary function variables; quality of life variables;patient diary variables;safety
Trial Locations
- Locations (1)
ALTANA Pharma
🇬🇧Cities in the United Kingdom, United Kingdom