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

This study has been completed.

First Received on December 1, 2008. Last Updated on December 2, 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:	Time Perspective: 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 Symbicort 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 ]

Estimated Enrollment:	1020
Study Start Date:	May 2009
Study Completion Date:	November 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
Buriram, Thailand
Research Site
Chanthaburi, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Mahasarakham, Thailand
Research Site
Nakhon Phanom, Thailand
Research Site
Nakhon Srithammarat, Thailand
Research Site
Nakhonpathom, Thailand
Research Site
Phattalung, Thailand
Research Site
Phitsanulok, Thailand
Research Site
Rayong, Thailand
Research Site
Roi Et, Thailand
Research Site
Samutsakhon, Thailand
Research Site
Surat Thani, Thailand
Research Site
Trang, 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:	Thanu Komolsai, MD, Medical Advisor, AstraZeneca (Thailand) Ltd.
ClinicalTrials.gov Identifier:	NCT00800241 History of Changes
Other Study ID Numbers:	NIS-RTH-SYM-2008/1
Study First Received:	December 1, 2008
Last Updated:	December 2, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Asthma
Symbicort SMART
Thai patient eligibility
Persistent asthma

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents

Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012