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)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Main Inclusion Criteria:
- 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 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
- History of life-threatening asthma
- Current smoking
Trial design
Primary purpose
Allocation
Interventional model
Masking
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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