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)
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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 lower leg growth in prepubertal children with mild persistent asthma. The study duration consists of a baseline period (2 weeks), a treatment period (2 weeks for each treatment), and a wash-out period (2 weeks). The study will provide further data on safety and tolerability of ciclesonide.
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Ages Eligible for Study:
6 Years to 12 Years (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Written informed consent by the patient's parent(s) or legal guardian(s) and by the patient, if capable
Good health with the exception of asthma
History of asthma for at least 6 months
Currently using rescue medication only
Main Exclusion Criteria:
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