- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00573222
Non-interventional Surveillance of Effectiveness of Symbicort® Maintenance And Reliever Therapy (Symbicort® SMART) in the Treatment of Moderate and Severe Asthma
November 30, 2010 updated by: AstraZeneca
This is a 3-month non-interventional, observational study on patients with moderate and severe asthma.
Study Overview
Study Type
Observational
Enrollment (Actual)
330
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Cakovec, Croatia
- Research Site
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Dubrovnik, Croatia
- Research Site
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Osijek, Croatia
- Research Site
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Pozega, Croatia
- Research Site
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Pula, Croatia
- Research Site
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Rijeka, Croatia
- Research Site
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Senj, Croatia
- Research Site
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Sibenik, Croatia
- Research Site
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Slavonskibrod, Croatia
- Research Site
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Vinkovci, Croatia
- Research Site
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Vukovar, Croatia
- Research Site
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Zadar, Croatia
- Croatia
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Zagreb, Croatia
- Research Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
pulmonology clinics
Description
Inclusion Criteria:
- Patients with moderate and severe asthma on Symbicort SMART treatment
Exclusion Criteria:
- Under 18 years old
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Anan Marija Gjurovic, AstraZeneca
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2007
Primary Completion (Actual)
May 1, 2008
Study Completion (Actual)
May 1, 2008
Study Registration Dates
First Submitted
December 13, 2007
First Submitted That Met QC Criteria
December 13, 2007
First Posted (Estimate)
December 14, 2007
Study Record Updates
Last Update Posted (Estimate)
December 1, 2010
Last Update Submitted That Met QC Criteria
November 30, 2010
Last Verified
November 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIS-RHR-SYM-2007/1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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