Efficacy and Safety of Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Asthma (12 to 70 y) (BY217/M2-013)
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 investigate the effect of roflumilast taken orally together with low dose inhaled corticosteroids on lung function. Roflumilast will be administered at one dose level once daily together with inhaled corticosteroids at one dose level twice daily. The study duration consists of a baseline period (2 to 6 weeks) and a treatment period (24 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:||A 24-Week, Double-Blind, Parallel Group, Placebo and Active Controlled Study to Investigate the Efficacy and Safety of Daily Oral Roflumilast Taken With Low Dose Inhaled Corticosteroids in Patients With Chronic Asthma|
- change in forced expiratory volume in 1 second from baseline to final visit.
- change from baseline to each visit for spirometry variables, forced vital capacity, mean expiratory flow, peak expiratory flow
- change from baseline to each visit based on diary data variables (asthma symptom scores: daytime, nighttime, and summary, use of rescue medication, diurnal variability)
- number of rescue free/symptom free days based on the diary card
- area under the curves over the full 24-week trial period for the diary variables
- number of exacerbations
- time to first exacerbation
- change from baseline according to the Asthma Quality of Life Questionnaire (AQLQ).
|Study Start Date:||April 2003|
Show 24 Study Locations
|Study Chair:||Dirk Bredenbröker, MD||Altana Pharma, D-78467 Konstanz, Germany|