Efficacy and Safety of Roflumilast in Patients with Asthma (BY217/M2-012)

Exclusion Criteria

• - Poorly controlled asthma or seasonal asthma
• - History of lower airway infection four weeks prior to visit 1
• - Chronic obstructive pulmonary disease (COPD) and/or other relevant lung disease
• - Patients using > 8-puffs/day-short-acting bronchodilator (beta-agonists) (more than 3 days per week on average) prior to visit 1
• - Clinically relevant abnormal laboratory values suggesting an undiagnosed disease, severe renal insufficiency, active hepatitis or an HIV infection
• - Diagnosis, treatment or remission of any cancer (other than basal cell carcinoma) within two years prior to visit 1
• - Patients with chronic heart failure
• - Suspected hypersensitivity and/or contraindication to roflumilast or albuterol/salbutamol
• - Female patients of childbearing potential not using adequate means of birth control or pregnant or breast-feeding females
• - Patients who have received any investigational medication or device in the month prior to visit 1 or who plan to use another investigational medication during the study