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

• Status: Completed
• Trial end date: 2006-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Ciclesonide

Criteria

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