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)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163371
- Lead Sponsor
- AstraZeneca
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method growth velocity of the right lower leg as measured by knemometry.
- Secondary Outcome Measures
Name Time Method weight and height HPA-axis function vital signs, including blood pressure, pulse rate lung function from spirometry asthma symptom score, use of rescue medication from diary adverse events physical examination laboratory investigation.
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇩🇰Kolding, Denmark