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Completed

NCT Number: NCT00576316

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Research Site

Kuala Lumpur, Malaysia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Symbicort Turbuhaler 160/4.5

Drug

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Acronym: SMARTER

Important dates

Study start
2008
Study completion
2008
First posted
Dec 19, 2007
Registry last updated
Dec 16, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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