KOrea COpd Subgroup Registry and Subtype Research

Официальное название

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

Обзор

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.

Подробное описание

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.

Первичные конечные точки

• Number of acute exacerbation [Срок оценки: 5 years]

Вторичные конечные точки (8)

• Pulmonary function tests [Срок оценки: 5 years]
• Modified Medical Research Council [mMRC] dyspnea scale [Срок оценки: 5 years]
• COPD Assessment Test (CAT) [Срок оценки: 5 years]
• 6-min walk distance (6MWD) [Срок оценки: 5 years]
• the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C) [Срок оценки: 5 years]
• Percentage of Participants with smoking history [Срок оценки: 5 years]
• Percentage of Participants with Other Relevant Diseases [Срок оценки: 5 years]
• COPD Treatment [Срок оценки: Through study completion, average 5 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

South Korea · 1 центр

• Konkuk University Hospital — Seoul

Публикации

• 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 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 15893923

Идентификаторы

NCT: NCT02800499 · KUH1010338

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗