Last updated on September 2018

Predictive Value of Inflammatory Biomarkers and FEV1 for COPD


Brief description of study

This is a multi-center, prospective, cohort study. A total of 10,000 people aged 4075 without lung disease will be recruited and followed for 3 years. By measure the rate of decline in forced expiratory volume at one secondFEV1 and baseline inflammatory biomarkers in exhaled breath condensate and peripheral blood, we aim to explore the predictive model for chronic obstructive pulmonary diseaseCOPD in China.

Detailed Study Description

This is a multi-center, prospective, cohort study. A total of 10,000 subjects aged 4075 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.

Clinical Study Identifier: NCT03532893

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