A Pharmaceopidemiological Study in Patients Who Use Symbicort SMART

This study is ongoing, but not recruiting participants.

First Received: July 17, 2007 Last Updated: September 7, 2009 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:	Case-Only, 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:

Estimated Enrollment:	1000
Study Start Date:	July 2007
Estimated Study Completion Date:	December 2009

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

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Tomas Andersson, MSD )
Study ID Numbers:	D5890C00017, GPRD
Study First Received:	July 17, 2007
Last Updated:	September 7, 2009
ClinicalTrials.gov Identifier:	NCT00503061 History of Changes
Health Authority:	United Kingdom: Independent Scientific Advisory Committee

Keywords provided by AstraZeneca:

pharmaceopidemiological
Symbicort SMART
GPRD

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