A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®
1 other identifier
observational
500
1 country
43
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2009
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
April 20, 2009
CompletedFirst Posted
Study publicly available on registry
April 21, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedMarch 31, 2011
March 1, 2011
April 20, 2009
March 30, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Use of rescue medication
daily during 6 month
Secondary Outcomes (3)
Quality of life
3 times during study
Efficacy variables
during 6 month
Safety variables
during 6 month
Study Arms (2)
1
Asthma patient with specific treatment
2
Asthma patient on different specific treatment compared to the other group
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
- ClinResearch, GmbHcollaborator
Study Sites (43)
Research Site
Aschaffenburg, Germany
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Bad Lippspringe, Germany
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Bad Sassendorf, Germany
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Bergkamen, Germany
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Braunschweig, Germany
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Buchholz, Germany
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Chemnitz, Germany
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Coswig, Germany
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Cottbus, Germany
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Dortmund, Germany
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Dresden, Germany
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Düsseldorf, Germany
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Frankfurt, Germany
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Fürth, Germany
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Gelsenkirchen, Germany
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Gütersloh, Germany
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Halle, Germany
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Hamburg, Germany
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Ketzin, Germany
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Köthen, Germany
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Leipzig, Germany
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Löhne, Germany
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Lübeck, Germany
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Lüdenscheid, Germany
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Marburg, Germany
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Marl, Germany
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Mittelbach, Germany
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Mühlhausen, Germany
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Mülheim, Germany
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München, Germany
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Oschersleben, Germany
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Potsdam, Germany
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Remscheid, Germany
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Saarlouis, Germany
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Schwetzingen, Germany
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Steinhagen, Germany
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Stockach, Germany
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Wedel, Germany
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Wesseling, Germany
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Weyhe, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Kai Richter, MD
AstraZeneca
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
April 20, 2009
First Posted
April 21, 2009
Study Start
April 1, 2009
Study Completion
June 1, 2010
Last Updated
March 31, 2011
Record last verified: 2011-03