A 24 Week, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Oral Roflumilast (250 mcg or 500 mcg) Daily in Patients With Asthma

Date de début de l'étude : 1 novembre 2003

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