Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)

Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma

The aim of this study is to evaluate the involvement of small airways in asthma, as determined by bronchial challenges, CT-scanning, and cellular markers of inflammation. Ciclesonide will be inhaled at one dose level once daily. The study duration consists of a baseline period (2 to 3 weeks) and a treatment period (5 to 6 weeks). The study will provide further data on safety and tolerability of ciclesonide.

Main Inclusion Criteria:

• Written informed consent
• History of bronchial asthma
• FEV1 more than or equal to 60% of predicted
• Stable asthma
• Patients who are in good health with the exception of asthma

Main Exclusion Criteria:

• Concomitant severe diseases, diseases expected to interfere with the outcome of the study, or diseases which are contraindications for the use of ICS
• COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
• Use of ICS 4 weeks before entry into the baseline period
• Pregnancy
• Intention to become pregnant during the course of the study
• Breast feeding
• Lack of safe contraception
• Use of other drugs not allowed
• Current smokers and ex-smokers with more than or equal to 10 pack-years