Efficacy and Safety of Roflumilast Taken in the Morning or Evening in Patients With Stable Asthma (12 to 70 y) (BY217/M2-015)
Bronchial asthma is among the world's most prevalent diseases. Roflumilast is a novel, orally active, selective enzyme inhibitor (phosphodiesterase 4 inhibitor), which has shown effectiveness in the treatment of asthma.
The aim of the study is to compare the effect of roflumilast on lung function, symptoms, and use of rescue medication in patients with stable asthma. Roflumilast will be administered orally either in the morning or in the evening at one dose level. The study duration consists of a baseline period (1 to 2 weeks) and a treatment period (6 weeks). The study will provide further data on safety, tolerability, and effectiveness of roflumilast.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||The MOVE-study: Morning Versus Evening Administration of 500 Mcg Roflumilast Once Daily for 6 Weeks in Patients With Asthma|
- mean change from randomization to endpoint in forced expiratory volume in one second.
- forced expiratory vital capacity
- peak expiratory flow
- morning and evening peak expiratory flow (patient's diary)
- symptom score and use of rescue medication (patient's diary)
- Asthma Control Questionnaire (ACQ)
- proportion of symptom-free days / rescue medication-free days asthma exacerbations.
|Study Start Date:||May 2004|
|Estimated Study Completion Date:||August 2005|
|Cities in Australia, Australia|
|Cities in Belgium, Belgium|
|Cities in France, France|
|Cities in South Africa, South Africa|
|Cities in Spain, Spain|
|Study Chair:||Dirk Bredenbroeker, MD||Altana Pharma, D-78467 Konstanz, Germany|
|Principal Investigator:||Eric D. Bateman, Prof||UCT Lung Institute|