Status:
COMPLETED
Efficacy of Ciclesonide Versus Budesonide in Patients With Asthma (18 to 75 y) (BY9010/M1-137)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- Main
- 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
- 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
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
End Date :
July 1 2005
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00163397
Start Date
January 1 2004
End Date
July 1 2005
Last Update
November 30 2016
Active Locations (6)
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1
Altana Pharma/Nycomed
Kota Bharu / Kelantan, Malaysia, 16150
2
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50586
3
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 50603
4
Altana Pharma/Nycomed
Kuala Lumpur, Malaysia, 56000