Asthma Control-A "Patient Follow up Programme" Maintenance and Reliever Therapy in a Single Inhaler

This study has been completed.

First Received: August 30, 2007 Last Updated: July 8, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00524641

Purpose

To investigate the change in patient's asthma symptom control using ACQ scores after 4 to 6 weeks of Symbicort Turbuhaler (budesonide/ formoterol) in SMART approach.

Condition
Asthma

Study Type:	Observational
Study Design:	Prospective
Official Title:	A Patient Follow-up Program to Assess Asthma Control in Patients Using Symbicort® as Maintenance and Relief Therapy in a Single Inhaler (Symbicort® SMART: Budesonide/Formoterol 160/4.5 Mcg, 1 or 2 Inhalations x 2 Times Plus Additional Inhalations as Needed)

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:

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	1254
Study Start Date:	July 2007
Study Completion Date:	April 2008
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

Hospital out-patient departments and private clinics in all areas of Vietnam

Criteria

Inclusion Criteria:

Asthma patients from both sexes, age 18 or older
Have already been on Symbicort SMART treatment
Willing to give written informed consents to participate in the program.

Exclusion Criteria:

Patients who are not willing to give written informed consent
Patients in emergency care for asthma at ICUs or COPD patients are excluded from the program.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524641

Locations

Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hanoi, Vietnam

Sponsors and Collaborators

AstraZeneca

Investigators

Study Chair:	Dinh Ngoc SY, MD	TB and Lung Disease Hospital, Hanoi
Study Chair:	Tran Van Ngoc, MD, PhD	Cho Ray Hospital
Study Chair:	Nguyen Hong Duc	Pharm Ngoc Thach Hospital
Study Chair:	Do Van Dung, MD, PhD	Ho Chi Minh City Univ of Medicine and Pharmacist

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	NIS-RVN-SYM-2007/1, NIS-R84-AST-2007/3
Study First Received:	August 30, 2007
Last Updated:	July 8, 2009
ClinicalTrials.gov Identifier:	NCT00524641 History of Changes
Health Authority:	Vietnam: Ho Chi Minh City Health Service

Keywords provided by AstraZeneca:

Asthma
Symbicort
NIS

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