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

December 17, 2007
November 30, 2010
January 2008
Not Provided
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
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.
Complete list of historical versions of study NCT00576316 on ClinicalTrials.gov Archive Site
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
The evaluate the clinical efficacy of Symbicort SMART approach by evaluating changes in ACQ scores after 6 months of treatment.
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Symbicort Maintenance and Reliever Therapy - Experience in Real Life Setting in Malaysia
Symbicort Maintenance And Reliever Therapy - Experience in Real Life Setting in Malaysia - SMARTER Study

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

Not Provided
Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Asthma
Drug: Symbicort Turbuhaler 160/4.5
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
201
November 2008
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Malaysia
 
NCT00576316
D5890L00027
No
Not Provided
AstraZeneca
Not Provided
Study Director: Akhmal Yusof, MD AstraZeneca
Principal Investigator: Aziah Ahmad Mahayiddin, MD Kuala Lumpur Hospital
AstraZeneca
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP