Effect of Inhaled Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (18 to 65 y) (BY9010/M1-129)
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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.
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Ages Eligible for Study:
18 Years to 65 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main 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