A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART

This study has been completed.

First Received on July 17, 2007. Last Updated on November 30, 2010 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00503061

Purpose

To investigate how common it is that patients using Symibort SMART take high average daily doses that are not considered appropriate by their physician (overuse) or are hospitalised due to their asthma at least partly due to underuse.

Condition
Bronchial Asthma

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	A Pharmaceopidemiological Study in Patients Who Use Symbicort Turbuhaler as Maintenance and Reliever Therapy (Symbicort SMART) Capturing Over Use and Under Use Via the General Practice Research Database

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:

Enrollment:	1000
Study Start Date:	June 2007
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Population comes from Primary Care Clinics and Pulmonary Experts

Criteria

Inclusion Criteria:

Asthma diagnosis, patient registered with the prescribing physician for at least one year before the qualifying prescription of Symbicort, prescription of Symbicort SMART after UK launch of the concept

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00503061

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Catriona McMahon, MD	AZ UK MC
Study Director:	Tomas Andersson, MD	AZ R&D Lund

More Information

No publications provided

Responsible Party:	Tomas Andersson, MSD, AstraZeneca Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00503061 History of Changes
Other Study ID Numbers:	D5890C00017, GPRD
Study First Received:	July 17, 2007
Last Updated:	November 30, 2010
Health Authority:	United Kingdom: Independent Scientific Advisory Committee

Keywords provided by AstraZeneca:

pharmaceopidemiological
Symbicort SMART
GPRD

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate

Hypersensitivity
Immune System Diseases
Symbicort
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 09, 2012