Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia

Phase 4

Completed

• Conditions: Asthma

• Registration Number: NCT00576316
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-12-17
• Study First Submitted QC: 2007-12-18
• Study First Posted: 2007-12-19
• Study Start: 2008-01
• Study Completion: 2008-11
• Results First Submitted: 2009-11-19
• Results First Submitted QC: 2009-11-19
• Results First Posted: 2009-12-29
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

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Exclusion Criteria

• Patients already on Symbicort SMART treatment.
• Patients who has respiratory tract infection 30 days before study enrolment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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	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 Outcome Measures

Name	Time	Method
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	Difference/change in ACQ-5 scores between baseline and mean of 3 months and 6 months after SMART treatment. ACQ-5 is a 5 question patient reported outcome measuring level of asthma control during the past 7 days and it is scored on scale of 0-6. 0 indicates no symptoms and 6 represents severe symptoms

Trial Locations

Locations (1)

Research Site; 🇲🇾 Kuala Lumpur, Malaysia