NCT02800499

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
191mo left

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress48%
Jan 2012Feb 2042

Study Start

First participant enrolled

January 1, 2012

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

June 4, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 15, 2016

Completed
25.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2042

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2042

Last Updated

March 6, 2024

Status Verified

March 1, 2024

Enrollment Period

30.1 years

First QC Date

June 4, 2016

Last Update Submit

March 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of acute exacerbation

    Number of events

    5 years

Secondary Outcomes (8)

  • Pulmonary function tests

    5 years

  • Modified Medical Research Council [mMRC] dyspnea scale

    5 years

  • COPD Assessment Test (CAT)

    5 years

  • 6-min walk distance (6MWD)

    5 years

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

    5 years

  • +3 more secondary outcomes

Study Arms (1)

KOCOSS

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

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chronic Obstructive Pulmonary Disease(COPD)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Konkuk University Hospital

Seoul, 05030, South Korea

Location

Related Publications (7)

  • 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.

    PMID: 18547365BACKGROUND
  • Department of Health. Our health, our lives our say. London: Department of Health 2006.

    BACKGROUND
  • 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.

    PMID: 16611654BACKGROUND
  • 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.

    PMID: 21342331BACKGROUND
  • 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.

    PMID: 18234906BACKGROUND
  • 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.

    PMID: 17090573BACKGROUND
  • 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.

    PMID: 15893923BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ki-Seok NA Jung, Doctor

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 4, 2016

First Posted

June 15, 2016

Study Start

January 1, 2012

Primary Completion (Estimated)

February 1, 2042

Study Completion (Estimated)

February 1, 2042

Last Updated

March 6, 2024

Record last verified: 2024-03

Locations