Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Comparison of Inhaled Ciclesonide (160 Mcg b.i.d. or 320 Mcg b.i.d.) and Fluticasone Propionate (250 Mcg b.i.d. or 500 Mcg b.i.d.) in Pretreated Patients With Mild to Moderate Asthma|
- AUC(0-24h)/24 h of serum cortisol level
- 24 h urinary cortisol excretion adjusted for creatinine.
- 8 am measurement of bone formation markers
- PC20FEV1 to methacholine
- PC20FEV1 to AMP
- lung function (FEV1, FVC)
- safety and tolerability.
|Study Start Date:||March 2003|
|Genk, Belgium, 3600|
|Ghent, Belgium, 9000|
|Lanaken, Belgium, 3620|
|Liege, Belgium, 4000|
|Liége, Belgium, 4000|
|Principal Investigator:||E. Derom, Professor||State University, Ghent, Belgium|