Long-Term Safety of Symbicort in Asthmatic Children - SAPLING
Phase 3
Completed
- Conditions
- Asthma
- Interventions
- Drug: budesonide/formoterol (Symbicort)Drug: budesonide (Pulmicort)
- Registration Number
- NCT00646529
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to assess the safety of Symbicort compared to Pulmicort in asthmatic children aged 6 to 11 years
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 175
Inclusion Criteria
- At least 6 and maximally 11 years of age
- Diagnosis of asthma
- Baseline lung function tests as determined by protocol and required and received daily treatment with inhaled corticosteroids for at least 4 weeks prior to study start
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Exclusion Criteria
- Has required treatment with any non-inhaled corticosteroids within the previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers
- Has had cancer in the previous 5 years or has a significant disease that may put the patient at risk in this study
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 budesonide/formoterol (Symbicort) budesonide/formoterol 2 budesonide (Pulmicort) budesonide
- Primary Outcome Measures
Name Time Method Long term safety profile of Symbicort compared to Pulmicort as determined by safety assessments detailed in the protocol 4 assessments within 26 week treatment period
- Secondary Outcome Measures
Name Time Method Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort 4 assessments within 26 week treatment period