Symbicort in Asthmatic Children - SEEDLING
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00651547
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare Symbicort with budesonide alone and formoterol alone in the treatment of asthma in children aged 6 to 11 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 405
Inclusion Criteria
- Baseline lung function tests results as determined by the protocol
- Required and received treatment with inhaled corticosteroids within the timeframe and doses specified in the protocol
Exclusion Criteria
- Has required treatment with non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has been hospitalised or required emergency treatment for asthma-related condition within previous 6 months
- Has had cancer within previous 5 years or has a significant disease, as judged by investigator, that may put the patient at risk in this study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 budesonide/formoterol - 2 budesonide - 3 formoterol -
- Primary Outcome Measures
Name Time Method Morning PEF Daily
- Secondary Outcome Measures
Name Time Method Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments Throughout the treatment period