Asthma
Conditions
Keywords
asthma, children, adolescents, Symbicort, budesonide/ formoterol, budesonide
Brief summary
The purpose of this study is to compare Symbicort with budesonide alone for the treatment of asthma in children aged 6 to 15 years
Interventions
DRUGbudesonide
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
6 Years to 15 Years
Healthy volunteers
No
Inclusion criteria
* At least 6 and maximally 15 years of age * Diagnosis of asthma and baseline lung function tests as determined by the protocol * Has required and received treatment with inhaled corticosteroids 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in evening PEF | Daily throughout the 12 week treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Lung function, asthma symptoms, use of rescue medication and parent/caregiver/physician reported outcomes | Daily throughout the 12 week treatment period |
| Routine safety assessments described in the protocol | 2-4 assessments within 12 week treatment period |
Outcome results
None listed