Asthma
Conditions
Brief summary
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort with conventional stepwise treatment according to asthma treatment guidelines in patients with persistent asthma
Interventions
DRUGBudesonide/formoterol Turbuhaler vs Conventional 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 3 months * Prescribed daily use of glucocorticosteroids at a dose \> 320 mcg/ day 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 my 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 | — |
| Asthma Control Questionnaire | — |
| Number of asthma exacerbations | — |
| Safety: Serious Adverse Events and discontinuations due to adverse events | — |
| All variables assessed over the 6 months treatment period | — |
| Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs) | — |
Countries
Chile, Croatia, Czechia, Greece, Iceland, Latvia, Lithuania, Portugal, Slovakia, Slovenia
Outcome results
None listed