Mild or Moderate Asthma
Conditions
Keywords
Asthma, inhaled corticosteroids, Symbicort, budesonide/formoterol, budesonide
Brief summary
The purpose of this study is to determine whether treatment with Symbicort for 12 weeks will improve lung function and symptoms of adults and adolescents with asthma.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
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 and/or lung treatments specified in the protocol within timeframe and doses specified in protocol.
Exclusion criteria
* Severe asthma * Has required treatment with any non-inhaled corticosteroid 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 |
|---|---|
| Change from start of treatment in evening pre-dose FEV1 | 2, 6 and 12 weeks after starting treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from before treatment in lung function, symptoms, use of rescue medication and patient-physician reported outcomes | Daily |
| Investigate safety profile of Symbicort and budesonide | Before and 2, 4, 12 weeks after start of treatment and 1 week after end of treatment |
Outcome results
None listed