## Protocol Section
### Identification Module
**NCT ID:** NCT01419379

**Acronym:** EPOCH

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

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

#### Organization Study ID Info
**ID:** RO-2455-401-KR
#### Organization
**Class:** INDUSTRY
**Full Name:** Takeda
#### Secondary ID Infos
**Domain:** WHO
**ID:** U1111-1142-0154
**Type:** REGISTRY
### Status Module
#### Completion Date
**Date:** 2013-01

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2013-04-18

**Type:** ESTIMATED

**Last Update Submit Date:** 2013-04-16

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2013-01

**Type:** ACTUAL

#### Start Date
**Date:** 2011-07

**Status Verified Date:** 2013-04

#### Study First Post Date
**Date:** 2011-08-18
**Type:** ESTIMATED
**Study First Submit Date:** 2011-08-17
**Study First Submit QC Date:** 2011-08-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Takeda

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** 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.

### Conditions Module

**Conditions:**

- COPD

**Keywords:**

- COPD exacerbation rate

### Design Module

#### Design Info

**Observational Model:** COHORT

#### Enrollment Info

**Count:** 1118

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Label:** 1

### Outcomes Module

#### Primary Outcomes

**Description:** 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)

**Measure:** To investigate exacerbation rate in patients suffering from COPD

**Time Frame:** 24 months

#### Secondary Outcomes

**Measure:** To investigate comorbidities of COPD

**Time Frame:** At screening and after 12 months

**Description:** 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.

**Measure:** To determine airflow obstruction through lung function test

**Time Frame:** 24 months

**Description:** Patients will complete CAT (COPD Assessment Test) questionnaire.

**Measure:** To assess COPD (through CAT)

**Time Frame:** At screening and after 12 months

**Description:** Medications for COPD treatment at the time of enrollment will be investigated.

**Measure:** To know the current use of medications for COPD treatment

**Time Frame:** At screening and after 12 months

**Measure:** To investigate mortality of COPD patients for 1 year period

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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 Age:** 40 Years

**Sampling Method:** PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

**Study Population:** Patients with COPD

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Busan

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 2:**

**City:** Chungcheongnam-do

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 3:**

**City:** Daegu

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 4:**

**City:** Daejon

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 5:**

**City:** Gangwon-do

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 6:**

**City:** Gwangju

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 7:**

**City:** Gyeongbuk

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 8:**

**City:** Gyeonggi-do

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 9:**

**City:** Gyeongsangnam-do

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 10:**

**City:** Incheon

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 11:**

**City:** Jeollanam-do

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 12:**

**City:** Jeonbuk

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 13:**

**City:** Seoul

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

**Location 14:**

**City:** Ulsan

**Country:** Korea, Republic of

**Facility:** Nycomed Investigational Site

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
