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

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ClinicalTrials.gov Identifier: NCT00576316
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : December 29, 2009
Last Update Posted : December 16, 2010
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Symbicort Turbuhaler 160/4.5 Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study
Study Start Date : January 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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 [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576316


Locations
Malaysia
Research Site
Kuala Lumpur, Malaysia
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Akhmal Yusof, MD AstraZeneca
Principal Investigator: Aziah Ahmad Mahayiddin, MD Kuala Lumpur Hospital

ClinicalTrials.gov Identifier: NCT00576316     History of Changes
Other Study ID Numbers: D5890L00027
First Posted: December 19, 2007    Key Record Dates
Results First Posted: December 29, 2009
Last Update Posted: December 16, 2010
Last Verified: November 2010

Keywords provided by AstraZeneca:
Asthma

Additional relevant MeSH terms:
Budesonide, Formoterol Fumarate Drug Combination
Anti-Asthmatic Agents
Respiratory System Agents