SYMPHONIE - A Comparison of Symbicort Single Inhaler and Conventional Best Practice for the Treatment of Persistent Asthma in Adolescents and Adults
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00259792
- 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
- Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition. Prescribed inhaled GCS at a dose of ³400 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
Exclusion Criteria
- Use of any b-blocking agent, including eye-drops, Use of oral GCS as maintenance treatment, A history of smoking ³ 10 pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
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, Satisfaction with Asthma Treatment Questionnaire, Safety: Serious Adverse Events and discontinuations due to adverse events
Trial Locations
- Locations (3)
Research Sites
🇫🇷Creteil, France
Research Site
🇫🇷Marcq En Baroeul, France
Research site
🇫🇷Luneville, France