Morning versus evening administration of 500µg Roflumilast once dailyfor 6 weeks in patients with asthma.

Phase 1

• Conditions: Asthma; MedDRA version: 5.1Level: lltClassification code 10003553

• Registration Number: EUCTR2004-001065-18-ES
• Lead Sponsor: ALTANA Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-09-29
• Study Completion: 2005-07-07
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 60

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

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified