The National Chronic Obstructive Pulmonary Disease Screening Program in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 800,000
- 试验地点
- 1
- 主要终点
- Lung function
研究概览
简要总结
The national COPD screening program is in a cross-sectional manner at the baseline, planning to recruit a total of 800,000 participants from 160 districts or counties (5,000 for each site on average) from 31 provinces, autonomous regions or municipalities directly under the central government of China. The filtered COPD high-risk population and confirmed COPD patients will be managed and followed up according to the standardized clinical guidelines. The major aims of the program are to estimate the prevalences of COPD high-risk population and under- or miss- diagnosed COPD patients, and to manage the development and outcomes of the disease.
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
- 35 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults aged between 35 and 75 years;
- •residents living in the survey area with more than 6 months in the past year.
排除标准
- •experienced myocardial infarction, stroke or shock in the past 3 months;
- •experienced severe cardiac insufficiency, severe arrhythmia or unstable angina pectoris in the past 4 weeks;
- •experienced massive hemoptysis in the past 4 weeks;
- •received chest, abdominal or ophthalmic surgery in the past 3 months;
- •have mental disorders (e.g. auditory hallucinations, visual hallucinations, taking antipsychotics, seizures requiring medication, etc.);
- •have cognitive impairment (e.g. dementia, comprehension impairment, etc.);
- •have uncontrolled hypertension (i.e. systolic blood pressure > 200 mmHg, diastolic blood pressure > 100 mmHg);
- •present with heart rate >120 beats/min;
- •have aortic aneurysm;
- •have severe hyperthyroidism;
- •are pregnant or lactating women;
- •experienced respiratory infectious diseases (e.g. tuberculosis, influenza, etc.) in the past month.
结局指标
主要结局
Lung function
时间窗: 2 years
The changes of lung function (e.g. FEV1, FVC, FEV1/FVC, etc.) (P.S.: it is hard to assume that the lung function would be improved or decling, especially for the pre- or early-COPD population)
次要结局
- Respiratory symptoms(2 years)
- Exacerbations(2 years)
研究者
Ting YANG
Prof.
China-Japan Friendship Hospital