STYLE - Symbicort Single Inhaler Therapy vs Conventional Therapy in Treatment of Persistent Asthma
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00252824
- Lead Sponsor
- AstraZeneca
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
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 exclusion criteria will be evaluated by the investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Time to first severe asthma exacerbation
- Secondary Outcome Measures
Name Time Method Number of asthma exacerbations Mean use of as-needed medication Prescribed asthma medication Asthma Control Questionnaire Asthma related costs (direct asthma medication, direct non-medication costs and indirect costs) Safety: Serious Adverse Events and discontinuations due to adverse events All variables assessed over the 6 months treatment period
Trial Locations
- Locations (2)
Research Site
🇸🇮Nova Gorica, Slovenia
Researh Site
🇭🇷Dubrovnik, Croatia