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 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 (12 weeks). The study will provide further data on safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
500
Altana Pharma/Nycomed
Ahmedabad, India
Altana Pharma/Nycomed
Bangalore, India
Altana Pharma/Nycomed
Chandigarh, India
FEV1 absolute values.
FEV1 as % of predicted
PEF from spirometry
diary based morning and evening PEF
diary based symptom score
diary based salbutamol MDI use
diurnal PEF fluctuation
drop-out rate due to asthma exacerbations
time until asthma exacerbation
number of symptom free- and rescue medication free days
number of days with asthma control
physical examination
vital signs
laboratory work-up
adverse events.
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Altana Pharma/Nycomed
Coimbatore, India
Altana Pharma/Nycomed
Coimbatore, India
Altana Pharma/Nycomed
Coimbatore, Tamilnadu, India
Altana Pharma/Nycomed
Delhi, India
Altana Pharma/Nycomed
Kolkata, India
Altana Pharma/Nycomed
Mumbai, India
Altana Pharma/Nycomed
Mumbai, India
...and 6 more locations