This is a Multicenter, Prospective and Retrospective and Descriptive Epidemiology Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Korea
NCT ID: NCT01419379
Last Updated: 2013-04-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1118 participants
OBSERVATIONAL
2011-07-31
2013-01-31
Brief Summary
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This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.
This study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months.
The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.
The 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment will be analyzed.
The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and COPD medications of retrospective and prospective studies for the 2 years as well as mortality rate.
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Detailed Description
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Conditions
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Study Design
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COHORT
Study Groups
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1
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
3. Patient with having past 1 year medical record at the investigational site
4. Patient who signed Informed Consent Form
Exclusion Criteria
2. Patients currently diagnosed with cancer
40 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Locations
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Nycomed Investigational Site
Busan, , South Korea
Nycomed Investigational Site
Chungcheongnam-do, , South Korea
Nycomed Investigational Site
Daegu, , South Korea
Nycomed Investigational Site
Daejeon, , South Korea
Nycomed Investigational Site
Gangwon-do, , South Korea
Nycomed Investigational Site
Gwangju, , South Korea
Nycomed Investigational Site
Gyeongbuk, , South Korea
Nycomed Investigational Site
Gyeonggi-do, , South Korea
Nycomed Investigational Site
Gyeongsangnam-do, , South Korea
Nycomed Investigational Site
Incheon, , South Korea
Nycomed Investigational Site
Jeollanam-do, , South Korea
Nycomed Investigational Site
Jeonbuk, , South Korea
Nycomed Investigational Site
Seoul, , South Korea
Nycomed Investigational Site
Ulsan, , South Korea
Countries
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Other Identifiers
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U1111-1142-0154
Identifier Type: REGISTRY
Identifier Source: secondary_id
RO-2455-401-KR
Identifier Type: -
Identifier Source: org_study_id
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