Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (6 to 11 y) (BY9010/M1-206)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163462
- Lead Sponsor
- AstraZeneca
- Brief Summary
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 once daily, using one of the two dose levels; 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 750
Inclusion Criteria
- History of persistent bronchial asthma for at least 6 months
- FEV1 50-90% of predicted
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 lung function
- Respiratory tract infection or asthma exacerbation within the last 30 days prior to entry into the study
- History of life-threatening asthma
- Premature birth
- Current smoking
- Smoking history with either equal or more than 10 pack-years
- 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 absolute values PD20FEV1 from methacholine challenge.
- Secondary Outcome Measures
Name Time Method morning and evening PEF from diary PEF from spirometry salbutamol MDI use from diary laboratory investigation HPA-axis function assessed by free cortisol concentration in 24 hour-urine samples. asthma symptom score from diary diurnal PEF fluctuation from diary dropout rate due to asthma exacerbations and time to the first asthma exacerbation percentage of asthma symptom-free days, rescue medication-free days, nocturnal awakening free days and days on which patients perceived asthma control interview administered PAQLQ(S), self-administered PACQLQ physical examination and vital signs FEV1 as % of predicted onset of effect assessed by morning PEF, asthma total symptom score and use of rescue medication AEs
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
πΏπ¦Wynberg, South Africa