Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
- Sponsor
- AstraZeneca
- Study ID
- NCT00430729
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 40 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Roflumilast — DRUG
Study Details
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).
Key Dates
- Start date
- Jan 31, 2003
- Status verified
- Sep 2016
Study Design
- Enrollment
- 1,100 participants
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Primary Outcome Measure
The frequency of patients experiencing at least one moderate or severe exacerbation during the treatment period.
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