- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01713075
Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for Chronic Obstructive Pulmonary Disease (COPD) Patients
October 27, 2016 updated by: AstraZeneca
Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for Long-term Use for COPD Patients
The purpose of the investigation is to confirm the safety and efficacy in long-term use of Symbicort Turbuhaler in patients with Chronic obstructive pulmonary disease (COPD) under the post-marketing actual use.
Study Overview
Status
Completed
Conditions
Detailed Description
Symbicort Turbuhaler 30/60 Special Clinical Experience Investigation for long-term use for COPD patients
Study Type
Observational
Enrollment (Actual)
1183
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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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
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time
Description
Inclusion Criteria:
- Among patients treated with Symbicort Turbuhaler due to chronic obstructive pulmonary disease(COPD), those who received the drug for the first time.
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
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Adverse event incidence
Time Frame: 1 year
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1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Clinical questionnaire about chronic obstructive pulmonary disease(CCQ)
Time Frame: At baseline, Week 12, Week 26, 1 year
|
At baseline, Week 12, Week 26, 1 year
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
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, 2012
Primary Completion (ACTUAL)
December 1, 2015
Study Completion (ACTUAL)
December 1, 2015
Study Registration Dates
First Submitted
October 19, 2012
First Submitted That Met QC Criteria
October 23, 2012
First Posted (ESTIMATE)
October 24, 2012
Study Record Updates
Last Update Posted (ESTIMATE)
October 28, 2016
Last Update Submitted That Met QC Criteria
October 27, 2016
Last Verified
October 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D589DL00001
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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