Efficacy of Ciclesonide vs Fixed Combination of Fluticasone Propionate/Salmeterol vs Placebo in Patients With Mild Persistent Asthma (12 to 75 y) (BY9010/M1-132)
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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.
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Layout table for eligibility information
Ages Eligible for Study:
12 Years to 75 Years (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Main Inclusion Criteria:
Clinical diagnosis of mild persistent asthma
Pre-treatment with SABAs only
FEV1 ≥80% predicted
Good health with the exception of asthma
Main Exclusion Criteria:
Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
COPD (chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in pulmonary function
Intention to become pregnant during the course of the study
Lack of safe contraception
Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years