A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®

This study is ongoing, but not recruiting participants.

First Received: April 20, 2009 Last Updated: November 11, 2009 History of Changes

Sponsor:	AstraZeneca
Collaborator:	CLINRESEARCH GMBH
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00884689

Purpose

The purpose of this study is to describe the use of rescue medication and quality of life in adult asthmatic patients, either treated with SYMBICORT SMART® (regular dose according to physician's prescription and the current summary of product characteristics - SPC) or treated with a free combination of ICS plus LABA plus as needed SABA prescribed by the physician.

Condition
Asthma

Study Type:	Observational
Study Design:	Case-Only
Official Title:	A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART® 1-2 Inhalations b.i.d. as Maintenance Therapy Plus Additional Inhalations As-needed, Compared to Patients Treated With a Free Combination of an Inhaled Glucocorticosteroid and an Inhaled Long Acting ß2-agonist Plus as Needed Inhalations of a Short Acting ß2 Agonist.

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:

Use of rescue medication [ Time Frame: daily during 6 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: 3 times during study ] [ Designated as safety issue: No ]
Efficacy variables [ Time Frame: during 6 month ] [ Designated as safety issue: No ]
Safety variables [ Time Frame: during 6 month ] [ Designated as safety issue: Yes ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	500
Study Start Date:	April 2009
Estimated Study Completion Date:	April 2010

Groups/Cohorts
1 Asthma patient with specific treatment
2 Asthma patient on different specific treatment compared to the other group

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

Asthma treatment will not be assigned randomly, but will be administered at the discretion of the physicians according to standard medical practice. Each site should enrol 5 patients using the Symbicort® SMART® principle and 5 patients being prescribed a free combination GCS / LABA treatment.

Criteria

Inclusion Criteria:

Confirmed diagnosis of asthma demonstrating a reversible obstruction during the last 5 years prior to visit 1.
Patients being prescribed either Symbicort SMART or a free combination of ICS and LABA with SABA as rescue inhaler and being on that treatment for at least 3 month.
A history (documented in the patient's file) of at least one severe asthma exacerbation within 24 months prior to visit 1 but not within the last 30 days prior to Visit 1.
A severe asthma exacerbation is defined as a deterioration of asthma leading to at least one of the following:
- Oral/systemic GCS treatment due to asthma for at least 3 days
- Unscheduled health-care visit due to asthmaHospitalization or emergency room visit because of asthma requiring treatment with oral/systemic GCS

Exclusion Criteria:

Intake of oral, rectal, or parenteral GCS within 30 days prior to visit
Use of ß-blocking agents
Respiratory infection affecting the asthma, as judged by the investigator, within 30 days prior to visit 1.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00884689

Locations

Germany
Research Site
Aschaffenburg, Germany
Research Site
Bad Lippspringe, Germany
Research Site
Bad Sassendorf, Germany
Research Site
Bergkamen, Germany
Research Site
Berlin, Germany
Research Site
Bochum, Germany
Research Site
Bonn, Germany
Research Site
Braunschweig, Germany
Research Site
Buchholz, Germany
Research Site
Chemnitz, Germany
Research Site
Coswig, Germany
Research Site
Cottbus, Germany
Research Site
Dortmund, Germany
Research Site
Dresden, Germany
Research Site
Dusseldorf, Germany
Research Site
Frankfurt, Germany
Research Site
Furth, Germany
Research Site
Gelsenkirchen, Germany
Research Site
Gutersloh, Germany
Research Site
Halle, Germany
Research Site
Hamburg, Germany
Research Site
Weyhe, Germany
Research Site
Kothen, Germany
Research Site
Leipzig, Germany
Research Site
Lohne, Germany
Research Site
Lubeck, Germany
Research Site
Ludenscheid, Germany
Research Site
Marburg, Germany
Research Site
Marl, Germany
Research Site
Mittelbach, Germany
Research Site
Muhlhausen, Germany
Research Site
Mulheim, Germany
Research Site
Munchen, Germany
Research Site
Oschersleben, Germany
Research Site
Potsdam, Germany
Research Site
Remscheid, Germany
Research Site
Saarlouis, Germany
Research Site
Schwetzingen, Germany
Research Site
Steinhagen, Germany
Research Site
Stockach, Germany
Research Site
Wedel, Germany
Research Site
Wesseling, Germany
Research Site
Ketzin, Germany

Sponsors and Collaborators

AstraZeneca

CLINRESEARCH GMBH

Investigators

Study Director:

Kai Richter, MD

AstraZeneca

More Information

No publications provided

Responsible Party:	Vice President Medical ( Dr. Kai Richter )
Study ID Numbers:	NIS-RDE-SYM-2009/1
Study First Received:	April 20, 2009
Last Updated:	November 11, 2009
ClinicalTrials.gov Identifier:	NCT00884689 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by AstraZeneca:

Symbicort SMART
Free Combination GCS/LABA treatment

Additional relevant MeSH terms:

Respiratory System Agents
Symbicort
Therapeutic Uses
Anti-Asthmatic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010