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Enrolling by invitationNCT02800499KOCOSSUpdated Aug 10, 2026

KOrea COpd Subgroup Registry and Subtype Research

An observational study in COPD, sponsored by Konkuk University Medical Center. Enrolling by invitation at 1 site in South Korea. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2026-08-10.

Sponsored by Konkuk University Medical Center · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
40 Years and older
Sex
All
01

Study summary

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.

Read the 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.

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Conditions studied

03

Who can participate

Ages eligible
40 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Chronic Obstructive Pulmonary Disease(COPD)

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • KOCOSS

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

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What researchers measure

Primary outcomes

  1. Number of acute exacerbation

    Number of events

    Time frame: 5 years

Secondary outcomes

  1. Pulmonary function tests

    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.

    Time frame: 5 years

  2. Modified Medical Research Council [mMRC] dyspnea scale

    mMRC dyspnea scale is five-point scale with higher scores indicating more severe dyspnea. We will assess mMRC at screening and every 6 months.

    Time frame: 5 years

  3. COPD Assessment Test (CAT)

    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.

    Time frame: 5 years

  4. 6-min walk distance (6MWD)

    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

    Time frame: 5 years

  5. the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C)

    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.

    Time frame: 5 years

  6. Percentage of Participants with smoking history

    we will assess smoking history at screening and every 6 months

    Time frame: 5 years

  7. Percentage of Participants with Other Relevant Diseases

    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).

    Time frame: 5 years

  8. COPD Treatment

    COPD treatments are defined as inhaled therapies, oral therapies and other therapies administered during the enrollment and influenza vaccination and smoking cessation therapy

    Time frame: Through study completion, average 5 years

06

Study locations

1 site
  • Konkuk University Hospital
    Seoul, Seoul 05030, South Korea
07

References and documents

Publications

  • Fromer L, Cooper CB. A review of the GOLD guidelines for the diagnosis and treatment of patients with COPD. Int J Clin Pract. 2008 Aug;62(8):1219-36. doi: 10.1111/j.1742-1241.2008.01807.x. Epub 2008 Jun 28. PubMed 18547365 ↗
  • Department of Health. Our health, our lives our say. London: Department of Health 2006.
  • Halbert RJ, Natoli JL, Gano A, Badamgarav E, Buist AS, Mannino DM. Global burden of COPD: systematic review and meta-analysis. Eur Respir J. 2006 Sep;28(3):523-32. doi: 10.1183/09031936.06.00124605. Epub 2006 Apr 12. PubMed 16611654 ↗
  • Yoo KH, Kim YS, Sheen SS, Park JH, Hwang YI, Kim SH, Yoon HI, Lim SC, Park JY, Park SJ, Seo KH, Kim KU, Oh YM, Lee NY, Kim JS, Oh KW, Kim YT, Park IW, Lee SD, Kim SK, Kim YK, Han SK. Prevalence of chronic obstructive pulmonary disease in Korea: the fourth Korean National Health and Nutrition Examination Survey, 2008. Respirology. 2011 May;16(4):659-65. doi: 10.1111/j.1440-1843.2011.01951.x. PubMed 21342331 ↗
  • Bednarek M, Maciejewski J, Wozniak M, Kuca P, Zielinski J. Prevalence, severity and underdiagnosis of COPD in the primary care setting. Thorax. 2008 May;63(5):402-7. doi: 10.1136/thx.2007.085456. Epub 2008 Jan 30. PubMed 18234906 ↗
  • Mannino DM, Sonia Buist A, Vollmer WM. Chronic obstructive pulmonary disease in the older adult: what defines abnormal lung function? Thorax. 2007 Mar;62(3):237-41. doi: 10.1136/thx.2006.068379. Epub 2006 Nov 7. PubMed 17090573 ↗
  • Mannino DM, Doherty DE, Sonia Buist A. Global Initiative on Obstructive Lung Disease (GOLD) classification of lung disease and mortality: findings from the Atherosclerosis Risk in Communities (ARIC) study. Respir Med. 2006 Jan;100(1):115-22. doi: 10.1016/j.rmed.2005.03.035. PubMed 15893923 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT02800499
Lead sponsor
Konkuk University Medical Center
Responsible party
Kwang-Ha Yoo (Professor, Konkuk University Medical Center) — Principal investigator
First posted
Jun 15, 2016
Start date
Dec 1, 2011
Primary completion
Dec 31, 2042 (estimated)
Completion
Dec 31, 2042 (estimated)
Last update
Aug 10, 2026

Study contacts

Ki-Seok NA Jung, Doctor
principal investigator · Hallym University Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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