Efficacy and safety of roflumilast taken in the morning or evening in patients with stable asthma (12 to 70 y) (BY217/M2-015)

Exclusion Criteria

• - Poorly controlled asthma: requirement of a course of oral and/or parenteral glucocorticosteroids 4 weeks prior to the baseline, or admission to hospital for asthma (including treatment in an emergency room) 4 weeks prior to the baseline period, or asthma exacerbation in the last 4 weeks prior to baseline period
• - Patient using regularly >8 puffs/day rescue medication prior to baseline
• - History of lower airway infection in the last 4 weeks prior to baseline period
• - Diagnosis of chronic obstructive pulmonary disease and/or other relevant lung diseases
• - Heavy smoker: currently: >20 cigarettes/day and/or >10 pack years, ex-smoker: with a smoking history of ≥10 pack years
• - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
• - Liver insufficiency (Child Pugh A or worse)
• - Active hepatitis
• - Known infection with HIV
• - Diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start
• - Alcohol and/or drug abuse
• - Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast) or rescue medication
• - Pregnancy or patient of childbearing potential who is not using reliable method of contraception
• - Patients not able to follow study procedures, e.g. due to language problems, psychological disorders
• - Suspected inability or unwillingness to comply with the study procedures