Efficacy of Ciclesonide Inhaled Once Daily Versus Other Corticosteroids Used for Treatment of Mild Asthma in Children (4 to 11 y) (BY9010/CA-101)
The aim of this study is to compare the efficacy of ciclesonide with respect to reduction of
the number of asthma exacerbations in children with mild persistent asthma. Treatment
medication will be administered as follows: ciclesonide will be inhaled once daily, using
one of the two dose levels versus placebo together with other corticosteroids used as
intermittent treatment. The study duration consists of a baseline period (3 to 4 weeks) and
a treatment period (12 months). The study will provide further data on safety and
tolerability of ciclesonide.
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone
propionate on the lung function, symptoms, use of rescue medication, and occurrence of side
effects (such as candidiasis, hoarseness) in adults with persistent asthma. Ciclesonide will
be inhaled twice daily at one dose level; fluticasone propionate will be inhaled twice daily
at one dose level. The study duration consists of a baseline period (2 weeks) and a
treatment period (24 weeks). The study will provide further data on safety and tolerability
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.
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