SALTO - Symbicort Single Inhaler Therapy Use in Adolescent Adults and Adults With Persistent Asthma
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00290264
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition.
- Prescribed inhaled GCS at a dose of ≥320 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.
- Known or suspected hypersensitivity to study therapy or excipients.
- A history of smoking ≥ 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 severe asthma exacerbations Mean use of as-needed medication Prescribed asthma medication Peak Expiratory Flow (PEF)
Trial Locations
- Locations (2)
Research Site
🇱🇺Warken, Luxembourg
Research site
🇱🇺Luxembourg, Luxembourg