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KOrea COpd Subgroup Registry and Subtype Research (KOCOSS)

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ClinicalTrials.gov Identifier: NCT02800499
Recruitment Status : Recruiting
First Posted : June 15, 2016
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
Kwang-Ha Yoo, Konkuk University Medical Center

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.

Condition or disease
COPD

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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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Domestic COPD Patients Registry Business and COPD Phenotype Research Based by Registry Data - Multi-centered Trial
Study Start Date : January 2012
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : January 2022

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



Primary Outcome Measures :
  1. Number of acute exacerbation [ Time Frame: 5 years ]
    Number of events


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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. 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.

  6. Percentage of Participants with smoking history [ Time Frame: 5 years ]
    we will assess smoking history at screening and every 6 months

  7. 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).

  8. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic Obstructive Pulmonary Disease(COPD)
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02800499


Contacts
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Contact: Kwang-Ha NA Yoo, Doctor 82-2-2030-7522 khyou@kuh.ac.kr
Contact: Hyun- Ae NA Kim, Bachelor 82-2-2030-5066 kha0014125@hanmail.net

Locations
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Korea, Republic of
Konkuk University Hospital Recruiting
Seoul, Korea, Republic of, 05030
Contact: Kwang-Ha NA Yoo, Doctor    82-2-2030-7522    khyou@kuh.ac.kr   
Contact: Hyun-Ae NA Kim, Bachelor    2-2-2030-5066    kha0014125@hanmail.net   
Sponsors and Collaborators
Konkuk University Medical Center
Investigators
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Principal Investigator: Ki-Seok NA Jung, Doctor Hallym University Medical Center
Additional Information:

Publications:
Department of Health. Our health, our lives our say. London: Department of Health 2006.

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Responsible Party: Kwang-Ha Yoo, Professor, Konkuk University Medical Center
ClinicalTrials.gov Identifier: NCT02800499    
Other Study ID Numbers: KUH1010338
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: March 7, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided