Efficacy and Safety of Roflumilast in Patients With Asthma (BY217/M2-012)
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 70 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Persistent bronchial asthma
No change in asthma treatment within 4 weeks prior to visit 1
Non-smoker or ex-smoker (for 12 months or longer)
Main 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