Asthma
Conditions
Brief summary
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.
Interventions
DRUGConventional Best Asthma Therapy
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 \>= 3 months * Prescribed daily use of glucocorticosteroids for at least 3 months prior to Visit 1
Exclusion criteria
* Smoking history \> 10 pack-years * Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to inclusion * Any significant disease or disorder that may jeopardize the safety of the patient. Additional inclusion and
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to first severe asthma exacerbation | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean use of as-needed medication | — |
| Prescribed asthma medication | — |
| Number of asthma exacerbations | — |
| Safety: serious adverse events and discontinuations due to adverse events | — |
| All variables assessed over the 6 month treatment period | — |
| Asthma Control Questionnaire | — |
Countries
Denmark, Finland, Norway
Outcome results
None listed