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

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2013-01-31

Brief Summary

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This study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study.

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.

Detailed Description

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Conditions

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COPD

Study Design

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Observational Model Type

COHORT

Study Groups

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1

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Over 40 years old
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

1. Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
2. Patients currently diagnosed with cancer
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Takeda

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nycomed Investigational Site

Busan, , South Korea

Site Status

Nycomed Investigational Site

Chungcheongnam-do, , South Korea

Site Status

Nycomed Investigational Site

Daegu, , South Korea

Site Status

Nycomed Investigational Site

Daejeon, , South Korea

Site Status

Nycomed Investigational Site

Gangwon-do, , South Korea

Site Status

Nycomed Investigational Site

Gwangju, , South Korea

Site Status

Nycomed Investigational Site

Gyeongbuk, , South Korea

Site Status

Nycomed Investigational Site

Gyeonggi-do, , South Korea

Site Status

Nycomed Investigational Site

Gyeongsangnam-do, , South Korea

Site Status

Nycomed Investigational Site

Incheon, , South Korea

Site Status

Nycomed Investigational Site

Jeollanam-do, , South Korea

Site Status

Nycomed Investigational Site

Jeonbuk, , South Korea

Site Status

Nycomed Investigational Site

Seoul, , South Korea

Site Status

Nycomed Investigational Site

Ulsan, , South Korea

Site Status

Countries

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South Korea

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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