Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 11:36 PM
Study NCT ID:
NCT03532893
Status:
COMPLETED
Last Update Posted:
2022-03-29
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Predictive Value of Inflammatory Biomarkers and FEV1 for COPD
Sponsor:
Peking University First Hospital
Organization:
Study Overview
Official Title:
Predictive Value of Combining Inflammatory Biomarkers and Rapid Decline of FEV1 for COPD in Chinese Population - a Prospective Cohort Study
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PIFCOPD
Brief Summary:
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.
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: