KOrea COpd Subgroup Registry and Subtype Research (KOCOSS)

March 4, 2024 updated by: Kwang-Ha Yoo, Konkuk University Medical Center

Domestic COPD Patients Registry Business and COPD Phenotype Research Based by Registry Data - Multi-centered Trial

The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective, non-interventional and observational study within the Korean COPD patients. The prevalence of early COPD (mild to moderate COPD based by 2011 GOLD(the Global Initiative for Chronic Obstructive Lung Disease) guideline) is high in Korea. However, the patients with early COPD are not underdiagnosed due to mild symptom. The purpose of this study is to investigate early COPD characteristics and disease course and to form a guideline for early detection of COPD patients and prevention of progression to severe COPD.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

This study is a multicentered, observational study of the patients with COPD who were enrolled in 45 tertiary and university-affiliated hospitals from December 2012 to now.

The initial evaluation for all patients includes pulmonary function tests (PFT), 6-min walk distance (6MWD), COPD Assessment Test (CAT), modified Medical Research Council (mMRC) dyspnea scale, and the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C), exacerbations in the previous 12 months, smoking status, patient-reported education level, medications and comorbidities.

Pulmonary function tests (PFTs) are performed every 6 months and CAT, mMRC and SGRQ-C are evaluated every 6 months and 6 min walt test is performed every years during the whole period of study.

All of the data were reported using case-report forms (CRFs) which are completed by physicians or trained nurses, and the patients are to be evaluated at regular 6-month intervals after the initial examination.

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Chronic Obstructive Pulmonary Disease(COPD)

Description

Inclusion Criteria:

  • Over 40 years old South Korean COPD patients(Bronchodilator test results FEV1/FVC <0.7)
  • COPD patients who complain of cough, sputum, dyspnea
  • Unrelated smoking history

Exclusion Criteria:

  • other disease like asthma patients which is similar to COPD symptoms.
  • patients who is not suitable for pulmonary function test and communication
  • myocardial infarction or cerebrovascular event within the previous 3 months
  • pregnants
  • patients who disagree with registration
  • rheumatoid patients
  • cancer patients(including metastatic cancer, leukemia, lymphoma)
  • irritable bowel syndrome
  • patients who use systemic steroids over 8 weeks due to other diseases except COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
KOCOSS
The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective, non-interventional observational study within the Korean COPD patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of acute exacerbation
Time Frame: 5 years
Number of events
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function tests
Time Frame: 5 years
COPD severity will be assessed based on post-bronchodilator Forced expiratory volume in one second(FEV) and FEV1/FVC(Forced vital capacity). FEV1 to forced vital capacity (FVC) :Mild - FEV1/FVC<0.7, FEV1 ≥80% normal Moderate - FEV1/FVC<0.7, FEV1 50-79% normal; Severe - FEV1/FVC<0.70, FEV1 30-49% normal; Very Severe - FEV1/FVC<0.70, FEV1 <30% predicted. We will measure spirometry at screening and every 6 months.
5 years
Modified Medical Research Council [mMRC] dyspnea scale
Time Frame: 5 years
mMRC dyspnea scale is five-point scale with higher scores indicating more severe dyspnea. We will assess mMRC at screening and every 6 months.
5 years
COPD Assessment Test (CAT)
Time Frame: 5 years
The CAT score was also used for evaluation of dyspnea. It consists of 8 items, each scored from 0 to 5, with higher scores indicating a more severe symptom.We will measure CAT at screening and every 6 months.
5 years
6-min walk distance (6MWD)
Time Frame: 5 years
The 6MWD has been used as a simple tool to assess overall exercise tolerance in COPD patients. We will measure 6 min walk distance by ATS guideline at screening and every 6 months during the follow-up period
5 years
the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C)
Time Frame: 5 years
to assess the health status from the patient's perspective .The SGRQ-C is a 14-item questionnaire that can be summarized as a total score, as well as by three component scores for symptoms, activities, and impacts. We will assess SGRQ at screening and every 6 months.
5 years
Percentage of Participants with smoking history
Time Frame: 5 years
we will assess smoking history at screening and every 6 months
5 years
Percentage of Participants with Other Relevant Diseases
Time Frame: 5 years
We will examine the relevant disease which is defined as respiratory diseases, cardiovascular diseases (ischaemic heart disease, heart failure, hypertension), and other diseases (osteoporosis, GERD(gastroesophageal reflux disease), hyperlipidemia, bronchiectasis, emphysema).
5 years
COPD Treatment
Time Frame: Through study completion, average 5 years
COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered during the enrollment and influenza vaccination and smoking cessation therapy
Through study completion, average 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Konkuk University Medical Center

Investigators

  • Principal Investigator: Ki-Seok NA Jung, Doctor, Hallym University Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2012

Primary Completion (Estimated)

February 1, 2042

Study Completion (Estimated)

February 1, 2042

Study Registration Dates

First Submitted

June 4, 2016

First Submitted That Met QC Criteria

June 9, 2016

First Posted (Estimated)

June 15, 2016

Study Record Updates

Last Update Posted (Actual)

March 6, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • KUH1010338

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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