Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma

This study has been completed.

First Received: December 13, 2007 Last Updated: July 16, 2009 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00573222

Purpose

This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.

Condition	Intervention
Asthma	Drug: Symbicort

Study Type:	Observational
Study Design:	Prospective
Official Title:	Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe 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:

To evaluate & describe asthma control in adult patients w/moderate to severe asthma treated w/Symbicort SMART following the frequency, type & severity of symptoms through the Asthma Control Questionnaire.

Secondary Outcome Measures:

to evaluate the safety of Symbicort SMART treatment through the number and type of reported adverse events 2. assessment of patient's satisfaction with the treatment 3.assessment of physician's satisfaction with the treatment

Biospecimen Retention: None Retained

Biospecimen Description:

Enrollment:	330
Study Start Date:	September 2007
Study Completion Date:	July 2008
Primary Completion Date:	May 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:	Non-Probability Sample

Study Population

pulmonology clinics

Criteria

Inclusion Criteria:

Patients with moderate and severe asthma on Symbicort SMART treatment

Exclusion Criteria:

Under 18 years old

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573222

Locations

Croatia
Research Site
Zagreb, Croatia
Research Site
Rijeka, Croatia
Research Site
Pula, Croatia
Research Site
Senj, Croatia
Croatia
Zadar, Croatia
Research Site
Sibenik, Croatia
Research Site
Vukovar, Croatia
Research Site
Cakovec, Croatia
Research Site
Slavonskibrod, Croatia
Research Site
Osijek, Croatia
Research Site
Pozega, Croatia
Research Site
Vinkovci, Croatia
Research Site
Dubrovnik, Croatia

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

Anan Marija Gjurovic

AstraZeneca

More Information

No publications provided

Study ID Numbers:	NIS-RHR-SYM-2007/1
Study First Received:	December 13, 2007
Last Updated:	July 16, 2009
ClinicalTrials.gov Identifier:	NCT00573222 History of Changes
Health Authority:	Not Required:

Keywords provided by AstraZeneca:

Asthma

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