Asthma MedDRA version: 5.1 Level: llt Classification code 10003553
Conditions
Sponsors
ALTANA Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - diagnosis of persistent bronchial asthma (GINA guidelines 2002) - 12 to 70 years old - baseline FEV1 50-85% in patients either untreated or receiving short-acting or long-acting bronchodilators, DSCG, nedocromil, anticholinergics, theophylline /aminophylline, lipoxygenase inhibitor, leukotriene antagonists, alone or in combination - baseline FEV1 60-90% in patients receiving not more than 500µg BDP-CFC or equivalent and/or in combination with any other asthma medication mentioned above Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: poorly controlled asthma diagnosis of COPD and/or other relevant lung diseases heavy smokers liver insufficiency, active hepatitis, known infection with HIV lower airway infection in the last 4 weeks prior to baseline period (B0) diagnosis or history of cancer (other than basal cell carcinoma) or recurrence within 5 years prior to study start alcohol or drug abuse suspected hypersensitivity and/ or contraindication to any ingredient of the study medication or rescue medication pregnancy, nursing, oocyte donation or oocyte implantation planned during the trial participation in another clinical study (use of investigational product) within 30 days preceding the baseline visit B0 or re-entry of patients already enrolled in this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of 500µg roflumilast p.o. once daily administered in the morning with the evening administration for 6 weeks on pulmonary function in patients with asthma;Secondary Objective: To compare symptoms and the use of rescue medication; to investigate safety and tolerability of roflumilast administered in the morning versus evening administration; to determine plasma levels of roflumilast and the major metabolite roflumilast N-oxide ;Primary end point(s): Mean change from randomization to endpoint in forced expiratory volume in one second (FEV1) | — |
Countries
Spain
Outcome results
None listed