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

Epidemiologic Review and Prospective Observation of COPD and Health in Korea

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.

Study Overview

• Status: Completed
• Conditions: COPD

• Study Type: Observational
• Enrollment (Actual): 1118

Contacts and Locations

Study Locations

• Korea, Republic of
  • Busan, Korea, Republic of
    • Nycomed Investigational Site
  • Chungcheongnam-do, Korea, Republic of
    • Nycomed Investigational Site
  • Daegu, Korea, Republic of
    • Nycomed Investigational Site
  • Daejon, Korea, Republic of
    • Nycomed Investigational Site
  • Gangwon-do, Korea, Republic of
    • Nycomed Investigational Site
  • Gwangju, Korea, Republic of
    • Nycomed Investigational Site
  • Gyeongbuk, Korea, Republic of
    • Nycomed Investigational Site
  • Gyeonggi-do, Korea, Republic of
    • Nycomed Investigational Site
  • Gyeongsangnam-do, Korea, Republic of
    • Nycomed Investigational Site
  • Incheon, Korea, Republic of
    • Nycomed Investigational Site
  • Jeollanam-do, Korea, Republic of
    • Nycomed Investigational Site
  • Jeonbuk, Korea, Republic of
    • Nycomed Investigational Site
  • Seoul, Korea, Republic of
    • Nycomed Investigational Site
  • Ulsan, Korea, Republic of
    • Nycomed Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with COPD

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
1

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Takeda

Study record dates

Study Major Dates

• Study Start: July 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): January 1, 2013

Study Registration Dates

• First Submitted: August 17, 2011
• First Submitted That Met QC Criteria: August 17, 2011
• First Posted (Estimate): August 18, 2011

Study Record Updates

• Last Update Posted (Estimate): April 18, 2013
• Last Update Submitted That Met QC Criteria: April 16, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: COPD exacerbation rate
• Other Study ID Numbers: RO-2455-401-KR; U1111-1142-0154 (Registry Identifier: WHO)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No