Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 Mcg Once Daily) Versus Placebo in Patients With Asthma|
- variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
- FVC% at PC20 AMP, SVC% at PC20 AMP
- regional air trapping
- bronchial and alveolar exhaled NO
- lung function variables
- non-cellular inflammatory markers.
- safety and tolerability.
|Study Start Date:||September 2003|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163345
|RB Groningen, Netherlands, 9700|
|Principal Investigator:||D.S. Postma, Prof.||University Hospital, Groningen, The Netherlands|