Back to resultsEfficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Primary Purpose
Asthma
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ciclesonide
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Asthma, Ciclesonide, Budesonide
Eligibility Criteria
Main Inclusion Criteria: During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent) FEV1 80 - 105% of predicted Healthy with the exception of asthma Written informed consent has been obtained Outpatients Patients who have a history of persistent bronchial asthma for at least 6 months Main Exclusion Criteria: Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period Pregnancy Intention to become pregnant during the course of the study Breast feeding Lack of safe contraception Patient is current smoker with 10 or more pack-years Patient is ex-smoker with 10 or more pack-years
Sites / Locations
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
- Altana Pharma/Nycomed
Outcomes
Primary Outcome Measures
FEV1 absolute values.
Secondary Outcome Measures
FEV1 as percent of predicted
FVC
PEF absolute values
morning and evening PEF from diary
diurnal PEF fluctuation
asthma symptom score from diary
use of rescue medication from diary
number of symptom free- and rescue medication free days
dropout rate due to asthma exacerbations
time until first asthma exacerbation
number of days with asthma control
onset of effect
subgroup analysis for ex/current smokers and non-smokers
AQLQ(S)
physical examination
vital signs
laboratory work-up
adverse events.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00163397
Brief Title
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Official Title
A Comparative Study of Inhaled Ciclesonide 160 mcg/Day vs Budesonide 400 mcg/Day in Patients With Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
July 2005 (Actual)
Study Completion Date
July 2005 (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 the study is to investigate the efficacy of ciclesonide versus budesonide on lung function, symptoms and use of rescue medication in patients with asthma. Ciclesonide and budesonide will be inhaled once daily at one dose level each. The study duration consists of a baseline period (1 to 4 weeks) and a treatment period (12 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, Budesonide
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Ciclesonide
Primary Outcome Measure Information:
Title
FEV1 absolute values.
Secondary Outcome Measure Information:
Title
FEV1 as percent of predicted
Title
FVC
Title
PEF absolute values
Title
morning and evening PEF from diary
Title
diurnal PEF fluctuation
Title
asthma symptom score from diary
Title
use of rescue medication from diary
Title
number of symptom free- and rescue medication free days
Title
dropout rate due to asthma exacerbations
Title
time until first asthma exacerbation
Title
number of days with asthma control
Title
onset of effect
Title
subgroup analysis for ex/current smokers and non-smokers
Title
AQLQ(S)
Title
physical examination
Title
vital signs
Title
laboratory work-up
Title
adverse events.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Main Inclusion Criteria:
During the last 4 weeks prior to baseline, treatment with an inhaled steroid (dosage: up to 250 mcg fluticasone propionate or equivalent)
FEV1 80 - 105% of predicted
Healthy with the exception of asthma
Written informed consent has been obtained
Outpatients
Patients who have a history of persistent bronchial asthma for at least 6 months
Main Exclusion Criteria:
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
Concomitant COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
An asthma exacerbation or an infection of the lower airways prior to entry into the baseline period
Pregnancy
Intention to become pregnant during the course of the study
Breast feeding
Lack of safe contraception
Patient is current smoker with 10 or more pack-years
Patient is ex-smoker with 10 or more 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
Kota Bharu / Kelantan
ZIP/Postal Code
16150
Country
Malaysia
Facility Name
Altana Pharma/Nycomed
City
Kuala Lumpur
ZIP/Postal Code
50586
Country
Malaysia
Facility Name
Altana Pharma/Nycomed
City
Kuala Lumpur
ZIP/Postal Code
50603
Country
Malaysia
Facility Name
Altana Pharma/Nycomed
City
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Facility Name
Altana Pharma/Nycomed
City
Taipei City 114
ZIP/Postal Code
886-114
Country
Taiwan
Facility Name
Altana Pharma/Nycomed
City
Taipei
Country
Taiwan
12. IPD Sharing Statement
Links:
URL
http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4522&filename=BY9010-M1-137-RDS-2006-12-03.pdf
Description
BY9010-M1-137-RDS-2006-12-03.pdf
Learn more about this trial
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
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