NCT00576316CompletedPhase 4
Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 201
- Locations
- 1
- Primary Endpoint
- Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Study Overview
Brief Summary
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of asthma for past 6 months and treated with inhaled glucocorticosteroids for at least 3 months.
- •Patients who asthma is classified as uncontrolled or partially controlled as defined by GINA 2006 guidelines.
Exclusion Criteria
- •Patients already on Symbicort SMART treatment.
- •Patients who has respiratory tract infection 30 days before study enrolment.
Outcomes
Primary Outcomes
Change in Satisfaction With Asthma Treatment Questionnaire (SATQ) Scores From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART
Time Frame: 6 months after each patient was initially treated with Symbicort SMART
Difference/change in SATQ score between baseline and mean of 3 months and 6 months after SMART treatment as analysed by paired t-test. SATQ is a patient reported questionnaire which consists of 26 questions and scored to a scale of 1-7, the higher score indicating a greater level of satisfaction
Secondary Outcomes
- Changes in Asthma Control Questionnaire (ACQ-5) Score From Baseline to the Mean of 3 Months and 6 Months After Patient Was Initially Treated With SMART(6 months after each patient was initially treated with Symbicort SMART)
Investigators
Study Sites (1)
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