- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01232348
Symbicort Turbuhaler 30/60 Clinical Experience Investigation (SURE)
December 6, 2011 updated by: AstraZeneca
The purpose of this study is to confirm the safety (ADR related to beta stimulant drugs, unexpected ADRs) and efficacy of Symbicort in daily practice and the control status on bronchial asthma and Patient satisfaction
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
3643
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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-
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Aichi, Japan
- Research Site
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Akita, Japan
- Research Site
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Aomori, Japan
- Research Site
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Chiba, Japan
- Research Site
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Ehime, Japan
- Research Site
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Fukui, Japan
- Research Site
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Fukuoka, Japan
- Research Site
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Fukushima, Japan
- Research Site
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Gifu, Japan
- Research Site
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Gunma, Japan
- Research Site
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Hiroshima, Japan
- Research Site
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Hokkaido, Japan
- Research Site
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Hyogo, Japan
- Research Site
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Ibaraki, Japan
- Research Site
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Ishikawa, Japan
- Research Site
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Iwate, Japan
- Research Site
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Kagawa, Japan
- Research Site
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Kagoshima, Japan
- Research Site
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Kanagawa, Japan
- Research Site
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Kochi, Japan
- Research Site
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Kumamoto, Japan
- Research Site
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Kyoto, Japan
- Research Site
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Mie, Japan
- Research Site
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Miyagi, Japan
- Research Site
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Miyazaki, Japan
- Research Site
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Nagano, Japan
- Research Site
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Nagasaki, Japan
- Research Site
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Nara, Japan
- Research Site
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Niigata, Japan
- Research Site
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Oita, Japan
- Research Site
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Okayama, Japan
- Research Site
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Okinawa, Japan
- Research Site
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Osaka, Japan
- Research Site
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Saga, Japan
- Research Site
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Saitama, Japan
- Research Site
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Shiga, Japan
- Research Site
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Shimane, Japan
- Research Site
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Shizuoka, Japan
- Research Site
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Tochigi, Japan
- Research Site
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Tokushima, Japan
- Research Site
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Tokyo, Japan
- Research Site
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Tottori, Japan
- Research Site
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Toyama, Japan
- Research Site
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Wakayama, Japan
- Research Site
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Yamagata, Japan
- Research Site
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Yamaguchi, Japan
- Research Site
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Yamanashi, Japan
- 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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Patients treated with Symbicort for the first time due to bronchial asthma
Description
Inclusion Criteria:
- Patients treated with Symbicort for the first time due to bronchial asthma
Exclusion Criteria:
-
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
Cohorts and Interventions
Group / Cohort |
|---|
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Symbicort
Those with an exposure
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Incidence of Adverse Events
Time Frame: Range of 12 weeks
|
Range of 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
The level of asthma control
Time Frame: Range of 12 weeks
|
Range of 12 weeks
|
|
The level of patient satisfaction with Symbicort
Time Frame: Range of 12 weeks
|
Range of 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yoshida Shigeru, MD, AstraZeneca K.K.
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
January 1, 2010
Primary Completion (Actual)
October 1, 2011
Study Completion (Actual)
October 1, 2011
Study Registration Dates
First Submitted
October 31, 2010
First Submitted That Met QC Criteria
October 31, 2010
First Posted (Estimate)
November 2, 2010
Study Record Updates
Last Update Posted (Estimate)
December 7, 2011
Last Update Submitted That Met QC Criteria
December 6, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D589IL00001
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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