Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Evaluation of Parameters of the Small Airways and Their Changes Under Treatment With Ciclesonide (320 mcg Once Daily) Versus Placebo in Patients With Asthma
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 asthma
Started Sep 2003
Typical duration for phase_3 asthma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 14, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2006
CompletedDecember 8, 2016
December 1, 2016
2.7 years
September 12, 2005
December 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
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.
Secondary Outcomes (1)
safety and tolerability.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (1)
Altana Pharma/Nycomed
RB Groningen, 9700, Netherlands
Related Publications (1)
Cohen J, Douma WR, ten Hacken NH, Vonk JM, Oudkerk M, Postma DS. Ciclesonide improves measures of small airway involvement in asthma. Eur Respir J. 2008 Jun;31(6):1213-20. doi: 10.1183/09031936.00082407. Epub 2008 Feb 20.
PMID: 18287130DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
AstraZeneca AstraZeneca
AstraZeneca
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 14, 2005
Study Start
September 1, 2003
Primary Completion
May 1, 2006
Study Completion
May 1, 2006
Last Updated
December 8, 2016
Record last verified: 2016-12