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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00576316
First received: December 17, 2007
Last updated: November 30, 2010
Last verified: November 2010
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00576316     History of Changes
Other Study ID Numbers: D5890L00027
Study First Received: December 17, 2007
Results First Received: November 19, 2009
Last Updated: November 30, 2010
Health Authority: Malaysia: Ministry of Health

Keywords provided by AstraZeneca:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Symbicort
Budesonide
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 22, 2014