Domestic COPD Patients Registry Business and COPD Phenotype Research Based by Registry Data - Multi-centered Trial
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Number of acute exacerbation
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
KOCOSS
The KOrea COpd Subgroup Study team (KOCOSS) cohort is an ongoing, longitudinal, prospective, non-interventional observational study within the Korean COPD patients
结局指标
主要结局
Number of acute exacerbation
时间窗: 5 years
Number of events
次要结局
- COPD Treatment(Through study completion, average 5 years)
- Pulmonary function tests(5 years)
- Modified Medical Research Council [mMRC] dyspnea scale(5 years)
- 6-min walk distance (6MWD)(5 years)
- the COPD-specific version of St. George's Respiratory Questionnaire (SGRQ-C)(5 years)
- Percentage of Participants with smoking history(5 years)
- Percentage of Participants with Other Relevant Diseases(5 years)
- COPD Assessment Test (CAT)(5 years)
研究者
Kwang-Ha Yoo
Professor
Konkuk University Medical Center