Back to resultsEfficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
Netherlands
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Small Airways
Eligibility 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
Sites / Locations
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
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 Outcome Measures
safety and tolerability.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163345
Brief Title
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2003 (undefined)
Primary Completion Date
May 2006 (Actual)
Study Completion Date
May 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Ciclesonide, Small Airways
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
20 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
variables of primary interest are FVC% at PC20 MCh, SVC% at PC20 MCh
Title
FVC% at PC20 AMP, SVC% at PC20 AMP
Title
regional air trapping
Title
bronchial and alveolar exhaled NO
Title
lung function variables
Title
non-cellular inflammatory markers.
Secondary Outcome Measure Information:
Title
safety and tolerability.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AstraZeneca AstraZeneca
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Altana Pharma/Nycomed
City
RB Groningen
ZIP/Postal Code
9700
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
18287130
Citation
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.
Results Reference
derived
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4498&filename=BY9010_M1-131%20Synopsis.AZCT.com%20posting.pdf
Description
BY9010_M1-131 Synopsis
Learn more about this trial
Efficacy of Ciclesonide on Small Airways in Patients With Stable Asthma (18 to 60 y) (BY9010/M1-131)
We'll reach out to this number within 24 hrs