OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)
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Ages Eligible for Study:
40 Years and older (Adult, Senior)
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 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
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