Efficacy and safety of oral roflumilast taken once daily in patients older than 40 years with chronic obstructive pulmonary disease (BY217/M2-119)

Exclusion Criteria

• - COPD exacerbation indicated by a treatment with systemic glucocorticosteroids
• - Lower respiratory tract infection
• - Diagnosis of asthma
• - Known alpha-1-antitrypsin deficiency
• - Need for long term oxygen therapy defined as longer or equal 16 hours/day
• - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation (as assessed by the investigator)
• - Known infection with HIV, active hepatitis and/or liver insufficiency (according to the Child Pugh score A or worse)
• - Diagnosis or history of cancer
• - Clinically significant cardiopulmonary abnormalities
• - Pregnancy, breast feeding, oocyte donation or oocyte implantation planned during the trial
• - Female patients of childbearing potential, not using reliable method of contraception for the entire study duration, post-menopausal > 1 year or who are not using any other method considered sufficiently reliable by the investigator in individual cases
• - Participation in another study (use of investigational product) within 30 days preceding the baseline visit or re-entry of patients already enroled in this trial
• - Alcohol or drug abuse
• - Inability to follow the study procedures due to e.g., language problems, physiological disorders
• - Use of not allowed drugs
• - Suspected hypersensitivity to the study medication or rescue medication