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

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

This study has been completed.

First Received: December 17, 2007 Last Updated: January 19, 2010 History of Changes

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:	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

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 ]

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 ]

Enrollment:	201
Study Start Date:	December 2007
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

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

Keywords provided by AstraZeneca:

Asthma

Additional relevant MeSH terms:

Respiratory System Agents
Bronchial Diseases
Immune System Diseases
Symbicort
Asthma
Anti-Asthmatic Agents
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010