MONO: Symbicort® Single Inhaler Therapy and Conventional Best Standard Treatment for the Treatment of Persistent Asthma in Adolescents and Adults
Phase 4
Completed
- Conditions
- Asthma
- Registration Number
- NCT00242411
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of the study is to compare the efficacy of a flexible dose of Symbicort (budesonide/formoterol) with conventional stepwise best standard treatment in patients with persistent asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1900
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 may 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 Number of asthma exacerbations Mean use of as-needed medication Prescribed asthma medication Asthma Control Questionnaire Safety: serious adverse events and discontinuations due to adverse events All variables assessed over the 6 month treatment period
Trial Locations
- Locations (1)
Research Site
🇳🇴Årnes, Norway