DESOLO - SiT Peri-Launch: A Comparison of Symbicort Single Inhaler Therapy and Conventional Best Practice for the Treatment of Persistent Asthma in Adults
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00252863
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to determine whether Symbicort dosed according to the Symbicort Maintenance and Reliever Therapy (SMART) concept is superior to standard asthma treatment according to the local German treatment guidelines.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1600
Inclusion Criteria
- Patients with asthma, either well-controlled on a regular therapy with a combination of long-acting beta-agonists and inhaled corticosteroids or symptomatic on therapy with inhaled corticosteroids alone.
Exclusion Criteria
- Any other significant lung disease other than asthma
- Any disease that might put patients at risk if they participate in the study
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 Health care contacts Asthma medication Prescribed asthma medication during the treatment period Number of severe asthma exacerbations Mean use of as-needed medication Change in forced expiratory volume in 1 second (FEV1) from the end of run-in to the end of the study period Asthma Control Questionnaire (ACQ) Patient's satisfaction with the treatment question Serious adverse events (SAEs) Discontinuations due to adverse events (AEs) Time lost from paid and unpaid work
Trial Locations
- Locations (1)
Research Site
🇩🇪Zwickau, Germany