Budesonide/Formoterol for Maintenance and Reliever Therapy Among Asthma Patients in Thailand

This study has been completed.

First Received: December 1, 2008 Last Updated: January 7, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00800241

Purpose

The purpose of this study is to determine the incidence of misuse, i.e., over-use and under-use, of Budesonide/formoterol for maintenance and reliever therapy in usual-care setting.

Condition
Asthma

Study Type:	Observational
Study Design:	Retrospective
Official Title:	Budesonide/Formoterol for Maintenance and Reliever Therapy: A Medication Use Evaluation Among Persistent Asthma Patients in General Practice in Thailand

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Number of budesonide/formoterol use per patient [ Time Frame: On the survey date ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1020
Study Start Date:	May 2009
Study Completion Date:	December 2009

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patient aged 12 years or older who established persistent asthma and currently treated with Symbicort SMART for 3 months or longer.

Criteria

Inclusion Criteria:

Established persistent asthma
Currently treated with Symbicort SMART for 3 months or longer

Exclusion Criteria:

currently participating or have participated in a study with an investigational compound within the last 30 days
current diagnosis of chronic obstructive pulmonary disease (COPD)
smoked more than 10 pack-year

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00800241

Locations

Thailand
Research Site
Roi Et, Thailand
Research Site
Nakhonpathom, Thailand
Research Site
Buriram, Thailand
Research Site
Surat Thani, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Nakhon Phanom, Thailand
Research Site
Trang, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Chanthaburi, Thailand
Research Site
Mahasarakham, Thailand
Research Site
Phattalung, Thailand
Research Site
Rayong, Thailand
Research Site
Samutsakhon, Thailand
Research Site
Nakhon Srithammarat, Thailand

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Bandit Thinkhamrop, PhD.	Department of Biostatistics and Demography, Faculty of Public Health, Khon Kaen University
Principal Investigator:	Watchara Boonsawat, MD, PhD	Department of Medicine, Faculty of Medicine, Khon Kaen University

More Information

No publications provided

Responsible Party:	AstraZeneca (Thailand) Ltd. ( Thanu Komolsai, MD, Medical Advisor )
Study ID Numbers:	NIS-RTH-SYM-2008/1
Study First Received:	December 1, 2008
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00800241 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Asthma
Symbicort SMART
Thai patient eligibility
Persistent asthma

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Symbicort
Bronchial Diseases
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Hormones
Adrenergic Agonists
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Therapeutic Uses

Formoterol
Immune System Diseases
Adrenergic beta-Agonists
Budesonide
Asthma
Anti-Asthmatic Agents
Glucocorticoids
Pharmacologic Actions
Autonomic Agents
Lung Diseases
Hypersensitivity, Immediate
Peripheral Nervous System Agents
Bronchodilator Agents
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010