SOLO-Symbicort® in the Treatment of Persistent Asthma in Adolescents & Adults
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00238784
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare Symbicort Single Inhaler treatment with the Best Conventional Practice in patients with persistent asthma
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1300
Inclusion Criteria
- Diagnosis of asthma < 3 months
- Prescribed daily use of glucocorticosteroids 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 Patient reported Outcomes All variables assessed over the 6 months treatment period Number of asthma exacerbations Health care resource use Mean use of as-needed medication Safety: Adverse Events, Serious Adverse Events and discontinuations due to Adverse Events Induced sputum will be sampled from a subset of patients Prescribed asthma medication
Trial Locations
- Locations (1)
Research Site
🇨🇦Brampton, Ontario, Canada