The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, symptoms, and use of rescue medication in children with persistent asthma. Ciclesonide will be inhaled once daily, using one of the two dose levels; fluticasone propionate will be inhaled at one dose level twice daily. The study duration consists of a baseline period (2 to 4 weeks) and a treatment period (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
750
FEV1 absolute values
PD20FEV1 from methacholine challenge.
FEV1 as % of predicted
PEF from spirometry
morning and evening PEF from diary
asthma symptom score from diary
salbutamol MDI use from diary
diurnal PEF fluctuation from diary
dropout rate due to asthma exacerbations and time to the first asthma exacerbation
percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control
onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication
interview administered PAQLQ(S), self-administered PACQLQ
physical examination and vital signs
laboratory investigation
AEs
HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples.
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Altana Pharma/Nycomed
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