Status:
COMPLETED
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such a...
Eligibility Criteria
Inclusion
- Main
- Written informed consent
- History of bronchial asthma for at least 6 months
- Pre-treatment with CFC-beclomethasone dipropionate (CFC-BDP) ≥ 1000 mcg/day or equivalent and a long-acting beta agonist (LABA) either in free or fixed combination
- FEV1 ≥ 80% of predicted
- Main
Exclusion
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids or contraindications for the use of LABAs
- COPD
- Smoking with ≥10 pack-years
- 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 :
November 1 2005
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00163319
Start Date
November 1 2004
End Date
November 1 2005
Last Update
December 2 2016
Active Locations (89)
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1
Altana Pharma/Nycomed
Brussels, Belgium, 1000
2
Altana Pharma/Nycomed
Brussels, Belgium, 1040
3
Altana Pharma/Nycomed
Brussels, Belgium, 1190
4
Altana Pharma/Nycomed
Halen, Belgium, 3545