NCT00076089CompletedPhase 3
Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. A 52-week, Multicenter, Double-blind Study With 500 mcg Roflumilast Once Daily Versus Placebo.
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,100
- Locations
- 40
- Primary Endpoint
- change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Study Overview
Brief Summary
The purpose of this study is to determine whether roflumilast is effective in the treatment of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double
Eligibility Criteria
- Ages
- 40 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Main 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 chest x-ray dated a maximum of 6 months prior to study baseline or a willingness to have a chest x-ray performed at baseline
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
Outcomes
Primary Outcomes
change in FEV1 from baseline during the treatment period; number of COPD exacerbations.
Secondary Outcomes
- pulmonary function variables
- number of COPD exacerbations of different type and various subgroups
- quality of life variables
- patient diary variables
- time to study withdrawal
- safety.
Investigators
Study Sites (40)
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