Asthma
Conditions
Keywords
Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol, children
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
Interventions
DRUGbudesonide/formoterol
DRUGbudesonide
DRUGformoterol
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Morning PEF | Daily |
Secondary
| Measure | Time frame |
|---|---|
| Lung function, asthma symptoms, use of rescue medication, adverse events and other safety assessments | Throughout the treatment period |
Outcome results
None listed