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

Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study

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

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Symbicort Turbuhaler 160/4.5

• Study Type: Interventional
• Enrollment (Actual): 201
• Phase: Phase 4

Contacts and Locations

Study Locations

• Malaysia
  • Kuala Lumpur, Malaysia
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months after each patient was initially treated with Symbicort SMART

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	6 months after each patient was initially treated with Symbicort SMART

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Study Director: Akhmal Yusof, MD, AstraZeneca; Principal Investigator: Aziah Ahmad Mahayiddin, MD, Kuala Lumpur Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Study Completion (Actual): November 1, 2008

Study Registration Dates

• First Submitted: December 17, 2007
• First Submitted That Met QC Criteria: December 18, 2007
• First Posted (Estimate): December 19, 2007

Study Record Updates

• Last Update Posted (Estimate): December 16, 2010
• Last Update Submitted That Met QC Criteria: November 30, 2010
• Last Verified: November 1, 2010

More Information

Terms related to this study

• Keywords: Asthma
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Anti-Asthmatic Agents; Respiratory System Agents; Budesonide, Formoterol Fumarate Drug Combination
• Other Study ID Numbers: D5890L00027