Comparison of the Efficacy/Safety of Symbicort® Turbuhaler®,Seretide™ Diskus™ 50/500 µg & Terbutaline Turbuhaler® 0.4 mg
Phase 3
Completed
- Conditions
- Asthma
- Registration Number
- NCT00242775
- Lead Sponsor
- AstraZeneca
- Brief Summary
The purpose of this study is to compare the efficacy and safety of a variable dose of Symbicort with a high fixed maintenance dose of another asthma medication, Seretide, in the treatment of asthma.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2100
Inclusion Criteria
- Diagnosed with asthma since at least 6 months prior to first visit
- Prescribed daily use of glucocorticosteroids for at least 3 months prior to first visit
- At least one asthma exacerbation more than one but less than twelve months prior to first visit
Exclusion Criteria
- Respiratory infection affecting asthma within 30 days before first visit
- Use of oral, rectal, or parenteral glucocorticosteroids for within 30 days before first visit
- 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 severe asthma exacerbations Mild asthma exacerbations FEV1 Patient-reported outcomes regarding disease status (inlc. PEF), collected via questionnaires and diaries Healthcare utilization Safety (adverse events) - all variables assessed over the 6 months treatment period
Trial Locations
- Locations (1)
Research Site
🇻🇳Ho Chi Minh, Vietnam