Efficacy of Ciclesonide Versus Fluticasone Propionate in Patients With Mild to Moderate Asthma (12 to 75 y) (BY9010/M1-142)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163423
- Lead Sponsor
- AstraZeneca
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 480
Inclusion Criteria
- Outpatients
- Written informed consent
- History of bronchial asthma for at least 6 months
- Good health with the exception of asthma
- Treated with inhaled steroids with a maximum daily constant dosage of 250 mcg fluticasone propionate or equivalent
- FEV1 80 - 105% of predicted
Main
Exclusion Criteria
- Concomitant severe diseases or diseases which are contraindications for the use of inhaled steroids
- COPD (i.e. chronic bronchitis or emphysema) and/or other relevant lung diseases causing alternating impairment in lung function
- Current smoking with more than 10 pack-years
- Previous smoking with more than 10 pack-years
- Use of systemic steroids 4 weeks (injectable depot steroids 6 weeks) before entry into the baseline period, or more than 2 times
- Pregnancy
- Intention to become pregnant during the course of the study
- Breast feeding
- Lack of safe contraception
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method FEV1 time to the first asthma exacerbation.
- Secondary Outcome Measures
Name Time Method adverse events number of patients with local oropharyngeal adverse events. percentage of rescue medication-free days physical examination asthma symptom score AQLQ(S) and EQ-5D FVC use of rescue medication vital signs percentage of days on which patients perceived asthma control percentage of nocturnal awakening-free days percentage of asthma symptom-free days standard laboratory work-up
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
πΏπ¦Wynberg, South Africa