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

COPD Clinical Trial

— EPOCH  

Official title:

Epidemiologic Review and Prospective Observation of COPD and Health in Korea

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419379
• Other study ID #: RO-2455-401-KR
• Secondary ID: U1111-1142-0154
• Status: Completed
• Phase: N/A
• First received: August 17, 2011
• Last updated: April 16, 2013
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: April 2013
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1118
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Cohort

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
Korea, Republic of	Nycomed Investigational Site	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

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	To investigate comorbidities of COPD		At screening and after 12 months	No
Secondary	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	No
Secondary	To assess COPD (through CAT)	Patients will complete CAT (COPD Assessment Test) questionnaire.	At screening and after 12 months	No
Secondary	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	No
Secondary	To investigate mortality of COPD patients for 1 year period		12 months	No