Asthma
Conditions
Keywords
Asthma
Brief summary
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of 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
* Diagnosed with asthma since at least 6 months prior to first visit * Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit * At least one asthma exacerbation more than one but less than twelve months prior to first visit
Exclusion criteria
* Respiratory infection affecting asthma within 30 days before first visit * Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit * 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 |
|---|---|
| Mild asthma exacerbations | — |
| FEV1 | — |
| Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries | — |
| Number of severe asthma exacerbations | — |
| Safety (adverse events) | — |
| - all variables assessed over the 6 months treatment period | — |
| Healthcare utilization | — |
Countries
Argentina, Australia, Brazil, Canada, China, France, Germany, India, Indonesia, Malaysia, Mexico, Philippines, Singapore, South Africa, Spain, Thailand, Vietnam
Outcome results
None listed