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)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Primary Purpose: Treatment
|Official Title:||Effect of Ciclesonide (320 Mcg/Day) vs Fluticasone Propionate (375 Mcg/Day) vs. Placebo on Short-term Linear Growth Rate and HPA-axis Function in Prepubertal Children With Mild Asthma|
- growth velocity of the right lower leg as measured by knemometry.
- HPA-axis function
- weight and height
- lung function from spirometry
- asthma symptom score, use of rescue medication from diary
- adverse events
- vital signs, including blood pressure, pulse rate
- physical examination
- laboratory investigation.
|Study Start Date:||September 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00163371
|Kolding, Denmark, 6000|
|Principal Investigator:||Søren Pedersen, Prof.||University of Odense, Kolding, Denmark|