Study identifier:BY9010/M1-129
ClinicalTrials.gov identifier:NCT00163332
EudraCT identifier:N/A
CTIS identifier:N/A
Comparison of inhaled ciclesonide (160 mcg b.i.d. or 320 mcg b.i.d.) and fluticasone propionate (250 mcg b.i.d. or 500 mcg b.i.d.) in pretreated patients with mild to moderate asthma
asthma
Phase 3
No
Ciclesonide
All
30
Interventional
18 Years - 65 Years
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment
Verified 01 Sept 2016 by AstraZeneca
AstraZeneca
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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.
Location
Location
Genk, Belgium, 3600
Location
Lanaken, Belgium, 3620
Location
Liege, Belgium, 4000
Location
Liége, Belgium, 4000
Location
Ghent, Belgium, 9000
Arms | Assigned Interventions |
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