Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
Status and phase
Completed
Phase 3
Conditions
Chronic Obstructive Pulmonary Disease
COPD
Treatments
Drug: Roflumilast
Details and patient eligibility
About
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).
Sex
All
Ages
40+ years old
Volunteers
No Healthy Volunteers
Inclusion and exclusion 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 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
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
Trial contacts and locations
14
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Data sourced from clinicaltrials.gov
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