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OpenTrials
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NCT Number: NCT01419379

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

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Key information

Conditions

COPD Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Nycomed Investigational Site, Busan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over 40 years old
  • Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
  • Patient with having past 1 year medical record at the investigational site
  • Patient who signed Informed Consent Form

Exclusion criteria

  • Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
  • Patients currently diagnosed with cancer

Treatment and study plan

Primary outcomes

  1. To investigate exacerbation rate in patients suffering from COPD

    Time frame: 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 outcomes

  1. To investigate comorbidities of COPD

    Time frame: At screening and after 12 months

  2. To determine airflow obstruction through lung function test

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

Epidemiologic Review and Prospective Observation of COPD and Health in Korea

Acronym: EPOCH

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Aug 18, 2011
Registry last updated
Apr 18, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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