Efficacy of Ciclesonide Inhaled Once Daily Versus Fluticasone Propionate Inhaled Twice Daily in Children With Asthma (4 to 15 y) (BY9010/M1-205)
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00163410
- 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 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 (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
- 500
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.
- Secondary Outcome Measures
Name Time Method FEV1 as % of predicted PEF from spirometry physical examination vital signs laboratory work-up adverse events. diary based morning and evening PEF diary based symptom score diary based salbutamol MDI use diurnal PEF fluctuation drop-out rate due to asthma exacerbations time until asthma exacerbation number of symptom free- and rescue medication free days number of days with asthma control
Trial Locations
- Locations (1)
Altana Pharma/Nycomed
🇮🇳Shastri Nagar, Jaipur, India