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Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia (SMARTER)
This study is currently recruiting participants.
Verified by AstraZeneca, December 2007
Sponsored by: AstraZeneca
Information provided by: AstraZeneca
ClinicalTrials.gov Identifier: NCT00576316
  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 IV

MedlinePlus related topics: Asthma
Drug Information available for: Symbicort
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study
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:
  • To evaluate the satisfaction level from a patient's perspective using the Symbicort SMART approach by evaluating the changes in Satisfaction of Asthma Treatment Questionnaire (SATQ) scores after 6 months.

Secondary Outcome Measures:
  • The evaluate the clinical efficacy of Symbicort SMART approach by evaluating changes in ACQ scores after 6 months of treatment.

Estimated Enrollment: 200
Study Start Date: December 2007
  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

Contacts
Contact: AstraZeneca Sdn Bhd Malaysia Clinical Study, Information +603 20892288

Locations
Malaysia
Research Site Recruiting
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

Study ID Numbers: D5890L00027
Study First Received: December 17, 2007
Last Updated: February 4, 2008
ClinicalTrials.gov Identifier: NCT00576316  
Health Authority: Malaysia: Ministry of Health

Keywords provided by AstraZeneca:
Asthma

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Symbicort
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Respiratory System Agents
Immune System Diseases
Bronchial Diseases
Therapeutic Uses
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009