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

Asthma Clinical Trial

— SMARTER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576316
• Other study ID #: D5890L00027
• Status: Completed
• Phase: Phase 4
• First received: December 17, 2007
• Last updated: November 30, 2010
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: November 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Malaysia: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Symbicort Turbuhaler 160/4.5

Locations

Country	Name	City	State
Malaysia	Research Site	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No