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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Takeda
ClinicalTrials.gov Identifier:
NCT01419379
First received: August 17, 2011
Last updated: April 16, 2013
Last verified: April 2013
  Purpose

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.


Condition
COPD

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Epidemiologic Review and Prospective Observation of COPD and Health in Korea

Further study details as provided by Takeda:

Primary Outcome Measures:
  • To investigate exacerbation rate in patients suffering from COPD [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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)


Secondary Outcome Measures:
  • To investigate comorbidities of COPD [ Time Frame: At screening and after 12 months ] [ Designated as safety issue: No ]
  • To determine airflow obstruction through lung function test [ Time Frame: 24 months ] [ Designated as safety issue: No ]

    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.


  • To assess COPD (through CAT) [ Time Frame: At screening and after 12 months ] [ Designated as safety issue: No ]
    Patients will complete CAT (COPD Assessment Test) questionnaire.

  • To know the current use of medications for COPD treatment [ Time Frame: At screening and after 12 months ] [ Designated as safety issue: No ]
    Medications for COPD treatment at the time of enrollment will be investigated.

  • To investigate mortality of COPD patients for 1 year period [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 1118
Study Start Date: July 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with COPD

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01419379

Locations
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, Korea, Republic of
Sponsors and Collaborators
Takeda
  More Information

No publications provided

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT01419379     History of Changes
Other Study ID Numbers: RO-2455-401-KR, U1111-1142-0154
Study First Received: August 17, 2011
Last Updated: April 16, 2013
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Takeda:
COPD exacerbation rate

Additional relevant MeSH terms:
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014