A Comparison of the Control of Asthma Provided by Symbicort® Turbuhaler® Versus Symbicort® Turbuhaler® Plus Pulmicort® Turbuhaler® Plus Terbutaline Turbuhaler®
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00244608
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Change in eosinophils in bronchial biopsies (first and last visit) and in sputum (5 times during the 12-month treatment period)
- Secondary Outcome Measures
Name Time Method Immunopathology and remodeling in biopsies Immunopathology and mediators in induced sputum Severe asthma exacerbations (number of and time to first) Forced expiratory volume in 1 second (FEV1) As-needed use Safety variables, including adverse events and vital signs All variables assessed over the 12-month treatment period
Trial Locations
- Locations (1)
Research Site
🇬🇧Southampton, United Kingdom