Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163345
- Lead Sponsor
- AstraZeneca
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method lung function variables bronchial and alveolar exhaled NO FVC% at PC20 AMP, SVC% at PC20 AMP non-cellular inflammatory markers. regional air trapping variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
- Secondary Outcome Measures
Name Time Method safety and tolerability.
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇳🇱RB Groningen, Netherlands