KOrea COpd Subgroup Registry and Subtype Research

COPD Clinical Trial

— KOCOSS  

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02800499
• Other study ID #: KUH1010338
• Status: Enrolling by invitation
• Start date: January 2012
• Est. completion date: February 2042

Study information

• Verified date: March 2024
• Source: Konkuk University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: February 2042
• Est. primary completion date: February 2042
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
Korea, Republic of	Konkuk University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Konkuk University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (7)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of acute exacerbation	Number of events	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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.	5 years
Secondary	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	5 years
Secondary	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.	5 years
Secondary	Percentage of Participants with smoking history	we will assess smoking history at screening and every 6 months	5 years
Secondary	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).	5 years
Secondary	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	Through study completion, average 5 years