Clincosm LogoSign in Get a demo

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

Sponsor
Takeda (Industry)
Overall Status
Completed
CT.gov ID
NCT01419379
Collaborator
(none)
1,118
Enrollment
14
Locations
18.1
Duration (Months)
79.9
Patients Per Site
4.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    1118 participants
    Observational Model:
    Cohort
    Official Title:
    Epidemiologic Review and Prospective Observation of COPD and Health in Korea
    Study Start Date :
    Jul 1, 2011
    Actual Primary Completion Date :
    Jan 1, 2013
    Actual Study Completion Date :
    Jan 1, 2013

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Outcome Measures

    Primary Outcome Measures

    1. To investigate exacerbation rate in patients suffering from COPD [24 months]

      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

    1. To investigate comorbidities of COPD [At screening and after 12 months]

    2. To determine airflow obstruction through lung function test [24 months]

      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.

    3. To assess COPD (through CAT) [At screening and after 12 months]

      Patients will complete CAT (COPD Assessment Test) questionnaire.

    4. To know the current use of medications for COPD treatment [At screening and after 12 months]

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

    5. To investigate mortality of COPD patients for 1 year period [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Nycomed Investigational Site Busan Korea, Republic of
    2 Nycomed Investigational Site Chungcheongnam-do Korea, Republic of
    3 Nycomed Investigational Site Daegu Korea, Republic of
    4 Nycomed Investigational Site Daejon Korea, Republic of
    5 Nycomed Investigational Site Gangwon-do Korea, Republic of
    6 Nycomed Investigational Site Gwangju Korea, Republic of
    7 Nycomed Investigational Site Gyeongbuk Korea, Republic of
    8 Nycomed Investigational Site Gyeonggi-do Korea, Republic of
    9 Nycomed Investigational Site Gyeongsangnam-do Korea, Republic of
    10 Nycomed Investigational Site Incheon Korea, Republic of
    11 Nycomed Investigational Site Jeollanam-do Korea, Republic of
    12 Nycomed Investigational Site Jeonbuk Korea, Republic of
    13 Nycomed Investigational Site Seoul Korea, Republic of
    14 Nycomed Investigational Site Ulsan Korea, Republic of

    Sponsors and Collaborators

    • Takeda

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Takeda
    ClinicalTrials.gov Identifier:
    NCT01419379
    Other Study ID Numbers:
    • RO-2455-401-KR
    • U1111-1142-0154
    First Posted:
    Aug 18, 2011
    Last Update Posted:
    Apr 18, 2013
    Last Verified:
    Apr 1, 2013
    Keywords provided by Takeda
    COPD exacerbation rate

    Study Results

    No Results Posted as of Apr 18, 2013