Efficacy of Symbicort Versus Its Monocomponents - SPRUCE 80/4.5
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- Registration Number
- NCT00651651
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare Symbicort with its monocomponents budesonide and formoterol in the treatment of asthma in children and adults
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
Inclusion Criteria
- At least 6 years of age
- Diagnosis of asthma
- Baseline lung function test results as determined by protocol and required and received treatment with inhaled corticosteroids and/or lung treatments specified in protocol within the timeframe and doses specified in the protocol
Exclusion Criteria
- Severe asthma
- Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Had cancer within previous 5 years or currently has any other significant disease or disorder as judged by the investigator
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 budesonide/formoterol Symbicort 2 budesonide budesonide 3 formoterol formoterol
- Primary Outcome Measures
Name Time Method 12 hour serial FEV1 measurements and withdrawals due to asthma exacerbation FEV1: before start of tretment and at 2 and 12 weeks after start of treatment. Withdrawals: throughout the treatment period
- Secondary Outcome Measures
Name Time Method Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments Throughout the treatment period