Asthma
Conditions
Keywords
Asthma, Ciclesonide, Small Airways
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.
Interventions
DRUGCiclesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| regional air trapping | — |
| variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh | — |
| FVC% at PC20 AMP, SVC% at PC20 AMP | — |
| non-cellular inflammatory markers. | — |
| bronchial and alveolar exhaled NO | — |
| lung function variables | — |
Secondary
| Measure | Time frame |
|---|---|
| safety and tolerability. | — |
Countries
Netherlands
Outcome results
None listed