This is a Multicenter, Prospective and Retrospective and Descriptive Epidemiology Study in Patients With Chronic Obstructive Pulmonary Disease (COPD) in Korea

Study Overview
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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.

Official Title
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Epidemiologic Review and Prospective Observation of COPD and Health in Korea

Conditions
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COPD

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Over 40 years old Patient with at least 1 year of medical history of COPD as defined by GOLD criteria Patient with having past 1 year medical record at the investigational site Patient who signed Informed Consent Form Exclusion Criteria: Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year Patients currently diagnosed with cancer

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate exacerbation rate in patients suffering from COPD | A total of 2 years of data will be evaluated based on annual evaluations: 1 year-before the enrollment (past 1 year) and 1 year-after the enrollment (1 year from the enrollment) | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To investigate comorbidities of COPD |  | At screening and after 12 months | 
| To determine airflow obstruction through lung function test | Lung function test data will be collected at the time of enrollment, 1 year before the enrollment (if available) and 1 year after the enrollment. For lung function data, the closest ones to the evaluation date among those obtained from ±3 months will be used. Items to be collected are pre/post bronchodilator FEV1, FVC, FEV1/FVC. | 24 months | 
| To assess COPD (through CAT) | Patients will complete CAT (COPD Assessment Test) questionnaire. | At screening and after 12 months | 
| To know the current use of medications for COPD treatment | Medications for COPD treatment at the time of enrollment will be investigated. | At screening and after 12 months | 
| To investigate mortality of COPD patients for 1 year period |  | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD exacerbation rate