Predictive Value of Combining Inflammatory Biomarkers and Rapid Decline of FEV1 for COPD in Chinese Population - a Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,385
- 试验地点
- 10
- 主要终点
- The incidence of COPD in the second and fourth year and the association between incidence of COPD and rapid decline of FEV1.
研究概览
简要总结
This is a multi-center, prospective, cohort study. A total of 10,000 people aged 40～75 without lung disease will be recruited and followed for 3 years. By measure the rate of decline in forced expiratory volume at one second（FEV1） and baseline inflammatory biomarkers in exhaled breath condensate and peripheral blood, we aim to explore the predictive model for chronic obstructive pulmonary disease（COPD） in China.
详细描述
This is a multi-center, prospective, cohort study. A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years. The Department of Respiratory and Critical Care of Peking University First Hospital is responsible for this research. Other 9 units participating in the study, include the The Second Hospital of Hebei Medical University, Henan Provincial People's Hospital, The Second Hospital of Jilin University, The First Affiliated Hospital of Xi'an Jiaotong University, Shandong Provincial Hospital Affiliated to Shandong University,Shanxi Dayi Hospital, Tianjin Medical University General Hospital, The Affiliated Hospital of Inner Mongolia Medical University,The First Hospital of Qinhuangdao. Some questionnaire such as St George's Respiratory Questionnaire (SGRQ), income class, educational level, comorbidity, smoking habit and biomass smoke exposure history will be collected. The baseline level of Interleukin 6 (IL-6), high-sensitivity C-reactive Protein (hs-CRP), microRNAs-23a (miR-23a) in peripheral blood and pH value in exhaled breath condensate (EBC) will be measured, lung spirometry will be tested in the first, second and fourth years. Primary outcome is the incidence of COPD, multivariate regression analysis will be used to establish the predictive model for COPD in China.
The study protocol has been approved by the Peking University First Hospital Institutional Review Board (IRB) (2018-31). Any protocol modifications will be submitted for the IRB review and approval.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •aged at 40-75 years old;
- •FEV1/FVC>70% after inhaled bronchodilator
- •have willing to participate in this study, follow the research program and have the ability to sign the informed consent;
- •lived in a community for more than 1 years and has no plans to move out in the next 4 years
- •can be contacted
排除标准
- •history of asthma, COPD, lung cancer, active pulmonary tuberculosis, bronchiectasis, diffuse lung disease (interstitial pneumonia, pulmonary sarcoidosis, occupational lung disease, sarcoidosis et al) and pleural disease;
- •history of lobectomy and / or lung transplantation;
- •predicted life expectancy less than 3 years;
- •history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
- •Alcoholism, drug abuse or abuse of toxic solvents;
- •Cannot finish long term follow-up or poor compliance;
- •Do not provide consent
结局指标
主要结局
The incidence of COPD in the second and fourth year and the association between incidence of COPD and rapid decline of FEV1.
时间窗: 4 years
FEV1/FVC(forced vital capacity)\<70% (after bronchial dilation test);Detect the decline of FEV1(%)by Vitalograph COPD6.
次要结局
- The association between incidence of COPD and the air pollution level in different provinces in China.(4 years)
- The mean decline rate of FEV1(4 years)
- The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease.(4 years)
- The association between decline rate of FEV1 and air pollution level(4 years)
- The association between serum miR-23a level and COPD incidence.(4 years)
- The correlation between the incidence of COPD and serum IL-6 level.(4 years)
- The association between incidence of COPD and other factors.(4 years)
- The correlation between the incidence of COPD and serum hs-CRP level.(4 years)
- The association between the pH value of EBC and COPD incidence.(4 years)
研究者
Guangfa Wang
Head of Respiratory and critical Medicine, Principal Investigator, Clinical Professor
Peking University First Hospital