Epidemiologic Review and Prospective Observation of COPD and Health in Korea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,118
- 试验地点
- 1
- 主要终点
- To investigate exacerbation rate in patients suffering from COPD
研究概览
简要总结
This study is designed as a multicenter, prospective and retrospective and descriptive epidemiology study.
This study is planned to evaluate 2 years of exacerbation in COPD patients and to investigate correlation of COPD disease progress and its exacerbation.
This study is designed with 6 months of subject enrollments, 12 months of retrospective study, and 12 months of prospective study. Hence, each patient will be participating in the study for 12 months, while the actual data collections from the patients will take a total of 24 months.
The statistical analysis of this study will be done twice, at the completion of 1 year retrospective data collection and at the completion of next 1 year follow-up.
The 1st statistical analysis of retrospective study includes exacerbation rate, duration of hospitalization for exacerbation and lung function test for the past 1 year from the enrollment and comorbidities, COPD assessment (CAT) and COPD medication at the enrollment will be analyzed.
The 2nd statistical analysis of prospective 1-year follow-up includes changes in exacerbation rates, comparison of lung function test results, comorbidities, COPD assessments (CAT) and COPD medications of retrospective and prospective studies for the 2 years as well as mortality rate.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
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
- •Patient with at least 1 year of medical history of COPD as defined by GOLD criteria
- •Patient with having past 1 year medical record at the investigational site
- •Patient who signed Informed Consent Form
排除标准
- •Patients who are currently involved in any other interventional studies or possible to be involved for the next 1 year
- •Patients currently diagnosed with cancer
结局指标
主要结局
To investigate exacerbation rate in patients suffering from COPD
时间窗: 24 months
A total of 2 years of data will be evaluated based on annual evaluations: * 1 year-before the enrollment (past 1 year) and * 1 year-after the enrollment (1 year from the enrollment)
次要结局
- To investigate comorbidities of COPD(At screening and after 12 months)
- To determine airflow obstruction through lung function test(24 months)
- To assess COPD (through CAT)(At screening and after 12 months)
- To know the current use of medications for COPD treatment(At screening and after 12 months)
- To investigate mortality of COPD patients for 1 year period(12 months)