The aim of the study is to compare the efficacy of ciclesonide versus fixed combination of fluticasone propionate/salmeterol versus placebo, on long-term asthma control in patients with mild persistent asthma. The study duration consists of a baseline period (2 weeks) and a treatment period (12 months). The study will provide further data on safety and tolerability of ciclesonide.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
630
time until the first severe asthma exacerbation occurs
number of poorly controlled asthma days.
percentage of days with asthma control
percentage of days with asthma symptoms
percentage of nocturnal awakenings due to asthma
asthma symptom score
number of inhalations of rescue medication
proportion of patients with severe asthma exacerbations
differences in morning PEF from diary
differences in FEV1 and FVC from spirometry
blood eosinophils
AQLQ(S)
health economic data
vital signs
laboratory work-up
adverse events.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Altana Pharma/Nycomed
Adelaide South Australia, Australia
Altana Pharma/Nycomed
Auchenflower, Australia
Altana Pharma/Nycomed
Bracken Ridge, Australia
Altana Pharma/Nycomed
Burwood, Australia
Altana Pharma/Nycomed
Camperdown, Australia
Altana Pharma/Nycomed
Carina Heights, Australia
Altana Pharma/Nycomed
Clayton, Australia
Altana Pharma/Nycomed
Concord, Australia
Altana Pharma/Nycomed
Geelong, Australia
Altana Pharma/Nycomed
Inala, Australia
...and 101 more locations