Asthma
Conditions
Keywords
asthma, children, Symbicort, budesonide/formoterol, Pulmicort, budesonide
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
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| Compare health economic outcomes and quality of life between patients treated with Symbicort and Pulmicort | 4 assessments within 26 week treatment period |
Outcome results
None listed