The aim of the study is to compare the efficacy of ciclesonide versus fluticasone propionate on lung function, time to first asthma exacerbation, asthma symptoms, use of rescue medication, and quality of life in patients with mild to moderate asthma. Ciclesonide will be inhaled at one dose level once daily; 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 (24 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
480
Altana Pharma/Nycomed
Gmünd, Austria
Altana Pharma/Nycomed
Linz, Austria
Altana Pharma/Nycomed
Linz, Austria
Altana Pharma/Nycomed
Neusiedl/See, Austria
Altana Pharma/Nycomed
Perg, Austria
Altana Pharma/Nycomed
Steyr, Austria
FEV1
time to the first asthma exacerbation.
FVC
asthma symptom score
use of rescue medication
AQLQ(S) and EQ-5D
percentage of days on which patients perceived asthma control
percentage of nocturnal awakening-free days
percentage of rescue medication-free days
percentage of asthma symptom-free days
physical examination
vital signs
standard laboratory work-up
adverse events
number of patients with local oropharyngeal adverse events.
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Altana Pharma/Nycomed
Wiener Neustadt, Austria
Altana Pharma/Nycomed
Brandon, Canada
Altana Pharma/Nycomed
Hamilton, Canada
Altana Pharma/Nycomed
London, Canada
...and 41 more locations