Status:
COMPLETED
Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
6-11 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide wi...
Eligibility Criteria
Inclusion
- Main
- History of persistent bronchial asthma for at least 6 months
- FEV1 50-90% of predicted
- 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 lung function
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- History of life-threatening asthma
- Premature birth
- Current smoking
- Smoking history with either equal or more than 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 :
October 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
750 Patients enrolled
Trial Details
Trial ID
NCT00163462
Start Date
October 1 2004
End Date
November 1 2005
Last Update
December 5 2016
Active Locations (57)
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1
Altana Pharma/Nycomed
Campinas - SP, Brazil, 13081970
2
Altana Pharma/Nycomed
Curitiba-PR, Brazil, 80060900
3
Altana Pharma/Nycomed
Florianópolis-SC, Brazil, 88040970
4
Altana Pharma/Nycomed
Porto Alegre-RS, Brazil, 90035003