Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France - Full Text View

Symbicort Usage in Asthma Treatment and Impact of a New Therapeutic Strategy on Compliance and Asthma Control in France (SYMBIOSE)

This study is currently recruiting participants.

Verified by AstraZeneca, November 2009

First Received: December 19, 2008 Last Updated: November 2, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00812357

Purpose

Descriptive pharmacoepidemiological study on the use of Symbicort Turbuhaler in the treatment of asthma in France and impact of a new therapeutic strategy on the compliance and control of asthma

Condition
Asthma

Study Type:	Observational
Study Design:	Cohort, Prospective
Official Title:	Descriptive Pharmacoepidemiological Study on the Use of Symbicort Turbuhaler in the Treatment of Asthma in France and Impact of a New Therapeutic Strategy on the Compliance and Control of Asthma

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:

Primary Outcome Measures:

Level of control of the asthma [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Evaluation of compliance with treatment [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	233
Study Start Date:	April 2009
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	October 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Patients treated with Symbicort basic treatment
2 Patients treated with Symbicort basic treatment + treatment of symptoms as needed

Eligibility

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

Study Population

Community sample

Criteria

Inclusion Criteria:

Asthmatic patients treated for this disease with Symbicort Turbuhaler
Patients monitored for asthma by the doctor for at least 12 months
Patients seen in outpatient care at the baseline visit
Patients agreeing to participate in the study

Exclusion Criteria:

Patients with any chronic lower respiratory disease other than asthma
Patients receiving anti-IgE agents in the last 4 months
Patients receiving desensitisation treatment outside of the maintenance phase
Patients deemed to be unable to respond to the study for linguistic or cognitive reasons

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00812357

Contacts

Contact: AstraZeneca France Clinical Study Information

+ 33 1 41 29 40 25

florence.thomas@astrazeneca.com

Show 449 Study Locations

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Stephane SCHÜCK, MD, MSc	KAPPA SANTE - Paris - France
Study Chair:	Michel AUBIER, MD, Professor	CHU Bichat - Service de pneumologie - Paris - France

More Information

No publications provided

Responsible Party:	AstraZeneca Pharmaceuticals ( Philippe MOUROUGA, MD, PhD, Public Health, Epidemiology and Economic Affairs Director )
Study ID Numbers:	NIS-RFR-SYM-2008/1
Study First Received:	December 19, 2008
Last Updated:	November 2, 2009
ClinicalTrials.gov Identifier:	NCT00812357 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency; France: Haute Autorité de Santé Transparency Commission

Keywords provided by AstraZeneca:

Symbicort Turbuhaler
asthma
cohort study
France

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