Status:
COMPLETED
Efficacy and Safety of Ciclesonide in Preschool Children With Asthma (2 to 6 Years) (BY9010/M1-207)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
2-6 years
Phase:
PHASE3
Brief Summary
The aim of the present study is to compare the efficacy of inhaled ciclesonide in pre-school children. Ciclesonide will be inhaled once daily, using one of three dose levels and tested versus placebo....
Eligibility Criteria
Inclusion
- Main
- Written informed consent by the parents or legal guardians of the patient
- Outpatients
- Good health with the exception of asthma
- Documented diagnosis of asthma for more than 6 months
- Use of rescue medication only or pretreatment with a controller drug
- Main
Exclusion
- Concomitant severe diseases
- Diseases contraindicated for the use of inhaled steroids
- Other relevant lung diseases causing impairment in pulmonary function
- Recurrent, episodic wheezing only
- History of life-threatening asthma
- History of any mechanical ventilation
- Clinically relevant abnormal laboratory values suggesting an unknown disease and requiring further clinical evaluation
- Premature birth (\< 32 weeks gestation)
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2007
Estimated Enrollment :
1000 Patients enrolled
Trial Details
Trial ID
NCT00163449
Start Date
November 1 2005
End Date
May 1 2007
Last Update
December 8 2016
Active Locations (96)
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1
Altana Pharma/Nycomed
Campinas - SP, Brazil, 13081970
2
Altana Pharma/Nycomed
Curitiba-PR, Brazil, 80060900
3
Altana Pharma/Nycomed
Paraná, Brazil, 80060900
4
Altana Pharma/Nycomed
Pinheiros Sao Paulo - SP, Brazil, 1246-000