An observational study in COPD and FEV1, sponsored by Peking University First Hospital. Completed at 10 sites in China. Open to participants aged 40 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-03-29.
Sponsored by Peking University First Hospital · Observational
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.
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.
Peking University First Hospital is the lead sponsor of 378 studies on the registry; 178 are open to participants now.
Counted across the registry records on this site, refreshed daily.
A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years.
Exclusion Criteria:
This is a multi-center,observational, 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. So there is no intervention in this study.
The incidence of COPD in the second and fourth year and the association between incidence of COPD and rapid decline of FEV1.
FEV1/FVC(forced vital capacity)\<70% (after bronchial dilation test);Detect the decline of FEV1(%)by Vitalograph COPD6.
Time frame: 4 years
The association between incidence of COPD and the air pollution level in different provinces in China.
Record data of air pollution in different provinces in China from the environmental monitoring website. And analyze the correlation between the COPD incidence and air pollution level.
Time frame: 4 years
The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease.
Record comorbidity condition data of human subjects, and then analyze the correlation between the COPD incidence and different comorbidity condition.
Time frame: 4 years
The mean decline rate of FEV1
Monitor pulmonary function decline in the second and the fourth year, then calculate the mean decline value.
Time frame: 4 years
The association between decline rate of FEV1 and air pollution level
Record data of air pollution in different provinces in China from the environmental monitoring website. And analyze the correlation between the decline rate of FEV1 and air pollution level.
Time frame: 4 years
The correlation between the incidence of COPD and serum IL-6 level.
Detect the serum IL-6 levels(ng/L), then analyze the correlation between the IL-6 levels and COPD incidence.
Time frame: 4 years
The correlation between the incidence of COPD and serum hs-CRP level.
Detect the serum hs-CRP levels(ng/L), then analyze the correlation between the hs-CRP levels and COPD incidence.
Time frame: 4 years
The association between the pH value of EBC and COPD incidence.
Detect the EBC pH value, then analyze the correlation between the EBC pH value and COPD incidence.
Time frame: 4 years
The association between serum miR-23a level and COPD incidence.
Detect the serum miR-23a level, then analyze the correlation between serum miR-23a level and COPD incidence.
Time frame: 4 years
The association between incidence of COPD and other factors.
The association between incidence of COPD and other factors (smoking habit, biomass exposure history, eating habit and incoming class).The incidence of COPD in the second and fourth year and the association between incidence of COPD and other factors (smoking habit(has or does not, if has: accumulative total smoking amount), biomass exposure history(yes or no), eating habit(light or greasy) and incoming class(family income per capita \>¥4500, or not)).
Time frame: 4 years
Plan to share: No
This study is completed, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Peking University First Hospital