Asthma
Conditions
Keywords
Asthma, inhaled cortocisteroids, Symbicort, budesonide/formoterol, Advair, fluticasone/salmeterol
Brief summary
The purpose of this study is to determine whether Symbicort compared with Advair, will be more effective in controlling asthma in adults and adolescents.
Interventions
DRUGfluticasone/salmeterol (Advair)
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma * Baseline lung function tests as determined by protocol * Required and received treatment with inhaled corticosteroids within timeframe and doses specified in protocol
Exclusion criteria
* Has required treatment with any non-inhaled corticosteroid within previous 30 days, sensitivity to drugs specified in the protocol, or requires treatment with a 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 |
|---|---|
| Asthma control assessed by asthma exacerbations | Continuosly throughout the treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy of Symbicort compared with Advair as assessed by use of rescue medication, asthma symptoms, lung function tests, quality of life reports, patient reported asthma control and patient satisfaction of Symbicort. | Daily and at 1, 3 and 6 months after start of treatmen |
| Use of medical resources and medication for the treatment of asthma. | Throughout the treatment period |
| Investigate safety profile of Symbicort compared to Advair | 1, 3 and 6 months after start of treatment and 1 week after end of tretment |
Outcome results
None listed