Status:
COMPLETED
Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
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 fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persisten...
Eligibility Criteria
Inclusion
- Main
- Clinical diagnosis of mild persistent asthma
- Pre-treatment with SABAs only
- FEV1 ≥80% predicted
- Good health with the exception of asthma
- Main
Exclusion
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
- Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Key Trial Info
Start Date :
September 1 2003
Trial Type :
INTERVENTIONAL
End Date :
October 1 2005
Estimated Enrollment :
630 Patients enrolled
Trial Details
Trial ID
NCT00163358
Start Date
September 1 2003
End Date
October 1 2005
Last Update
November 30 2016
Active Locations (111)
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1
Altana Pharma/Nycomed
Adelaide South Australia, Australia, 5000
2
Altana Pharma/Nycomed
Auchenflower, Australia, QLD 4066
3
Altana Pharma/Nycomed
Bracken Ridge, Australia, QLD 4017
4
Altana Pharma/Nycomed
Burwood, Australia, NSW 2134