Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Ciclesonide (80 Mcg Once Daily in the Evening) and Fluticasone Propionate (100 Mcg Twice Daily) in Patients With Mild to Moderate Asthma|
- time to the first asthma exacerbation.
- asthma symptom score
- use of rescue medication
- AQLQ(S) and EQ-5D
- percentage of days on which patients perceived asthma control
- percentage of nocturnal awakening-free days
- percentage of rescue medication-free days
- percentage of asthma symptom-free days
- physical examination
- vital signs
- standard laboratory work-up
- adverse events
- number of patients with local oropharyngeal adverse events.
|Study Start Date:||November 2004|
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|Principal Investigator:||Ronald Dahl, Prof.||Aarhus University Hospital, Aarhus, Denmark|