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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576316
First Posted: December 19, 2007
Last Update Posted: December 16, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
AstraZeneca
  Purpose
The purpose of the study is to evaluate the satisfaction level of patients using the Symbicort SMART approach for their asthma management.

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

Study Type: Interventional
Study Design: 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

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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


Enrollment: 201
Study Start Date: January 2008
Study Completion Date: November 2008
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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.
  Contacts and Locations
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
  More Information

ClinicalTrials.gov Identifier: NCT00576316     History of Changes
Other Study ID Numbers: D5890L00027
First Submitted: December 17, 2007
First Posted: December 19, 2007
Results First Submitted: November 19, 2009
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