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

Sponsor:	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

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:

MedlinePlus related topics: Asthma

Drug Information available for: Symbicort

U.S. FDA Resources

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 February 12, 2012