Clinical trial NCT02800499: KOrea COpd Subgroup Registry and Subtype Research
Official title: Domestic COPD Patients Registry Business and COPD Phenotype Research Based by Registry Data - Multi-centered Trial
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: COPD
Lead sponsor: Konkuk University Medical Center
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 2000
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Chronic Obstructive Pulmonary Disease(COPD)

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.

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.

Eligibility 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

Primary outcomes:
measure: Number of acute exacerbation
timeFrame: 5 years
Secondary outcomes:
measure: Pulmonary function tests
timeFrame: 5 years
measure: Modified Medical Research Council [mMRC] dyspnea scale
timeFrame: 5 years
measure: COPD Assessment Test (CAT)
timeFrame: 5 years
measure: 6-min walk distance (6MWD)
timeFrame: 5 years
measure: the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C)
timeFrame: 5 years
measure: Percentage of Participants with smoking history
timeFrame: 5 years
measure: Percentage of Participants with Other Relevant Diseases
timeFrame: 5 years
measure: COPD Treatment
timeFrame: Through study completion, average 5 years
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
Study officials:
affiliation: Hallym University Medical Center
name: Ki-Seok NA Jung, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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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.
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.