Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease. Ratio-Study. (BY217/M2-112)
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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).
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Ages Eligible for Study:
40 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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