Predictive Value of Inflammatory Biomarkers and FEV1 for COPD (PIFCOPD)

Predictive Value of Combining Inflammatory Biomarkers and Rapid Decline of FEV1 for COPD in Chinese Population - a Prospective Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: COPD; FEV1
• Intervention / Treatment: Other: No intervention

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.

• Study Type: Observational
• Enrollment (Actual): 10385

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100034
      • Peking University First Hospital
  • Hebei
    • Qinhuangdao, Hebei, China
      • The First Hospital of Qinhuangdao
    • Shijiazhuang, Hebei, China
      • The Second Hospital of Hebei Medical University
  • Henan
    • Zhengzhou, Henan, China
      • Henan Provincial People's Hospital
  • Inner Mongolia
    • Hohhot, Inner Mongolia, China
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jilin
    • Changchun, Jilin, China
      • The Second Hospital of Jilin University
  • Shandong
    • Jinan, Shandong, China
      • Shandong Provincial Hospital Affiliated to Shandong University
  • Shanxi
    • Taiyuan, Shanxi, China
      • The First Affiliated Hospital of Shanxi Medical University
    • Xi'an, Shanxi, China
      • The First Affiliated Hospital of Xi'an Jiaotong University
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Medical University General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years.

Description

Inclusion Criteria:

1. aged at 40-75 years old;
2. FEV1/FVC>70% after inhaled bronchodilator
3. have willing to participate in this study, follow the research program and have the ability to sign the informed consent;
4. lived in a community for more than 1 years and has no plans to move out in the next 4 years
5. can be contacted

Exclusion Criteria:

1. 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;
2. history of lobectomy and / or lung transplantation;
3. predicted life expectancy less than 3 years;
4. history of severe psychiatric illnesses, mental disorders, neurological disorders, malignant tumors, chronic liver disease, heart failure, autoimmune diseases, chronic kidney disease;
5. Alcoholism, drug abuse or abuse of toxic solvents;
6. Cannot finish long term follow-up or poor compliance;
7. Do not provide consent

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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)).	4 years

Collaborators and Investigators

• Sponsor: Peking University First Hospital
• Collaborators: The Second Hospital of Hebei Medical University; First Affiliated Hospital Xi'an Jiaotong University; Shandong Provincial Hospital; Henan Provincial People's Hospital; Tianjin Medical University General Hospital; Second Hospital of Jilin University; The Affiliated Hospital of Inner Mongolia Medical University; Shanxi Dayi Hospital; The First Hospital of Qinhuangdao

Publications and helpful links

General Publications

• Wang Y, Liao J, Zhong Y, Zhang C, Li X, Wang G. Predictive Value of Combining Inflammatory Biomarkers and Rapid Decline of FEV1 for COPD in Chinese Population: A Prospective Cohort Study. Int J Chron Obstruct Pulmon Dis. 2019 Dec 5;14:2825-2833. doi: 10.2147/COPD.S223869. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): October 9, 2021

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: May 21, 2018
• First Posted (Actual): May 22, 2018

Study Record Updates

• Last Update Posted (Actual): March 29, 2022
• Last Update Submitted That Met QC Criteria: March 27, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: Inflammatory biomarkers; EBC; COPD incidence; Decline in FEV1; microRNA-23a
• Other Study ID Numbers: 2017YFC1309500-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No