The aim of the study is to investigate the effect of ciclesonide versus fluticasone propionate versus placebo on airway hyperresponsiveness and on the hypothalamic-pituitary-adrenal axis (HPA axis). Treatment medication will be administered as follows: ciclesonide or fluticasone propionate will be inhaled twice daily, using one of the two dose levels. The study duration consists of a baseline period (4 to 6 weeks), five treatment periods (9 days each), and a washout period between treatments (4 to 12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
30
Altana Pharma/Nycomed
Genk, Belgium
Altana Pharma/Nycomed
Ghent, Belgium
Altana Pharma/Nycomed
Lanaken, Belgium
Altana Pharma/Nycomed
Liège, Belgium
Altana Pharma/Nycomed
Liége, Belgium
AUC(0-24h)/24 h of serum cortisol level
24 h urinary cortisol excretion adjusted for creatinine.
8 am measurement of bone formation markers
PC20FEV1 to methacholine
PC20FEV1 to AMP
lung function (FEV1, FVC)
pharmacokinetics
safety and tolerability.
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