Asthma
Conditions
Brief summary
The purpose of this study is to determine if a flexible dose of Symbicort has a similar effect on the airways of patients with asthma as a higher fixed-dose of Symbicort with additional glucocorticosteroids added.
Interventions
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of asthma for at least 6 months * Prescribed daily use of glucocorticosteroids for at least 3 months prior to visit one
Exclusion criteria
* Respiratory infection affecting asthma within 30 days prior to study * Intake of oral, rectal, or parenteral glucocorticosteroids within 30 days prior to study * Any significant disease or disorder that may jeopardize the safety of the patient
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period) | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunopathology and mediators in induced sputum | — |
| Severe asthma exacerbations (number of and time to first) | — |
| Forced expiratory volume in 1 second (FEV1) | — |
| Immunopathology and remodeling in biopsies | — |
| Safety variables, including adverse events and vital signs | — |
| All variables assessed over the 12-month treatment period | — |
| As-needed use | — |
Countries
Denmark, France, Germany, Spain, Sweden, United Kingdom
Outcome results
None listed