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)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163358
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 630
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
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
- Current smokers ≥10 pack-years and ex-smokers with ≥10 pack-years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method number of poorly controlled asthma days. time until the first severe asthma exacerbation occurs
- Secondary Outcome Measures
Name Time Method adverse events. percentage of days with asthma control percentage of days with asthma symptoms number of inhalations of rescue medication proportion of patients with severe asthma exacerbations blood eosinophils percentage of nocturnal awakenings due to asthma asthma symptom score differences in morning PEF from diary differences in FEV1 and FVC from spirometry AQLQ(S) health economic data vital signs laboratory work-up
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇪🇸Valencia, Spain