Status:
COMPLETED
Effects of Inhaled Ciclesonide Versus Fluticasone Propionate Versus Placebo on Lower Leg Growth in Prepubertal Children With Mild Persistent Asthma (6 to 12 y) (BY9010/M1-208)
Lead Sponsor:
AstraZeneca
Conditions:
Asthma
Eligibility:
All Genders
6-12 years
Phase:
PHASE3
Brief Summary
The aim of the study is to compare the effects of ciclesonide inhaled at one dose level twice daily versus fluticasone propionate inhaled at one dose level twice daily versus placebo, on short-term lo...
Eligibility Criteria
Inclusion
- Main
- Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
- Prepubertal stage
- Good health with the exception of asthma
- History of asthma for at least 6 months
- Currently using rescue medication only
- Main
Exclusion
- Childbearing potential (beyond menarche)
- Concurrent diseases or conditions which may subsequently affect growth
- COPD or relevant lung diseases causing alternating impairment in lung function
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- History of life-threatening asthma
- Current smoking
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
End Date :
December 1 2005
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT00163371
Start Date
September 1 2005
End Date
December 1 2005
Last Update
December 1 2016
Active Locations (1)
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1
Altana Pharma/Nycomed
Kolding, Denmark, 6000