Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163332
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- Patients who have had a history of bronchial asthma for at least 6 months
- FEV1 >60% of predicted for at least 24 h
- Patients who are hyperresponsive to methacholine and to AMP
- Patients who are in good health with the exception of asthma
Main
Exclusion Criteria
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- Patients suffering from COPD and/or other relevant lung diseases except asthma
- Current smokers and ex-smokers both with ≥10 pack years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method AUC(0-24h)/24 h of serum cortisol level 24 h urinary cortisol excretion adjusted for creatinine.
- Secondary Outcome Measures
Name Time Method pharmacokinetics lung function (FEV1, FVC) safety and tolerability. 8 am measurement of bone formation markers PC20FEV1 to methacholine PC20FEV1 to AMP
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇧🇪Liége, Belgium