Status:
COMPLETED
A 6 Months NIS to Evaluate the Use of Rescue Medication and Quality of Life in Adult Asthmatic Subjects Treated With Symbicort® SMART®
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
ClinResearch, GmbH
Conditions:
Asthma
Eligibility:
All Genders
18+ years
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 presc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT00884689
Start Date
April 1 2009
End Date
June 1 2010
Last Update
March 31 2011
Active Locations (43)
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1
Research Site
Aschaffenburg, Germany
2
Research Site
Bad Lippspringe, Germany
3
Research Site
Bad Sassendorf, Germany
4
Research Site
Bergkamen, Germany