OPUS Study: Effect of Roflumilast on Exacerbation Rate in Patients With Chronic Obstructive Pulmonary Disease (BY217/M2-111)

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