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

Main Inclusion Criteria:

• Written informed consent
• Diagnosis of persistent chronic bronchial asthma, according to Global Initiative for Asthma (GINA) guidelines
• The patient has been receiving BDP - CFC ≤1000 mcg per day or equivalent for the previous four weeks
• FEV1 between 60 and 90% predicted at visit 1
• No change in asthma treatment within 4 weeks prior to visit 1

Main 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