NCT00252863CompletedPhase 3
A Comparison of Symbicort Single Inhaler Therapy (Symbicort Turbuhaler 160/4.5 µg, 1 Inhalation b.i.d. Plus as Needed) and Conventional Best Practice for the Treatment of Persistent Asthma in Adults - a 26-Week, Randomised, Open-Label, Parallel-Group, Multicentre Study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 1,600
- Locations
- 157
- Primary Endpoint
- Time to first severe asthma exacerbation
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Time to first severe asthma exacerbation
Secondary Outcomes
- Health care contacts
- Asthma medication
- 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
- Prescribed asthma medication during the treatment 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
Investigators
Study Sites (157)
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