Status:
COMPLETED
Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality...
Eligibility Criteria
Inclusion
- Main
- Outpatients
- Written informed consent
- History of bronchial asthma for at least 6 months
- Good health with the exception of asthma
- Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
- FEV1 80 - 105% of predicted
- Main
Exclusion
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- Current smoking with more than 10 pack-years
- Previous smoking with more than 10 pack-years
- Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Key Trial Info
Start Date :
November 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT00163423
Start Date
November 1 2004
End Date
January 1 2006
Last Update
December 8 2016
Active Locations (51)
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1
Altana Pharma/Nycomed
Gmünd, Austria, 3950
2
Altana Pharma/Nycomed
Linz, Austria, 4020
3
Altana Pharma/Nycomed
Linz, Austria, 4040
4
Altana Pharma/Nycomed
Neusiedl/See, Austria, 7100