Efficacy and Safety of Oral Roflumilast Taken with Low Dose Inhaled Corticosteroids in Patients with Asthma (12 to 70 y) (BY217/M2-013)

Exclusion Criteria

• - Patients with poorly controlled asthma defined as requiring a course of oral or parenteral corticosteroids, admission to hospital for asthma (including treatment in an emergency room), or exacerbation of asthma in the four weeks prior to visit 1
• - Patients who suffer from seasonal asthma alone or patients who are likely to have a major exacerbation of their asthma due to seasonal effects during the study run-in or treatment period
• - A history of lower airway infection in the four weeks prior to visit 1
• - A diagnosis of chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease (e.g. cystic fibrosis, bronchiectasis)
• - Heavy smoker currently smoking >20 cigarettes per day and/or >10 pack years or the patient is an ex-smoker who has smoked >10 pack years
• - Patients using >8 puffs/day relief medication regularly prior to visit 1
• - Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
• - A diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
• - Patients with chronic heart failure class III or IV (New York Heart Association)
• - Suspected hypersensitivity and/or contraindication to any ingredients of the study medication (roflumilast, BDP, or salbutamol)
• - A history of alcoholism or substance abuse within the 12 months prior to visit 1
• - Pregnancy or women of childbearing potential who are not using a reliable method of contraception