Status:
COMPLETED
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
Brief 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 a...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00163345
Start Date
September 1 2003
End Date
May 1 2006
Last Update
December 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Altana Pharma/Nycomed
RB Groningen, Netherlands, 9700