Asthma
Conditions
Keywords
Asthma, Symbicort, budesonide/formoterol, budesonide, formoterol
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
Interventions
DRUGbudesonide/formoterol
DRUGbudesonide
DRUGformoterol
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| 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