PIFCOPD: Predictive Value of Inflammatory Biomarkers and FEV1 for COPD

Sponsor

Peking University First Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03532893

Collaborator

The Second Hospital of Hebei Medical University (Other), Henan Provincial People's Hospital (Other), Second Hospital of Jilin University (Other), First Affiliated Hospital Xi'an Jiaotong University (Other), Shandong Provincial Hospital (Other), Shanxi Dayi Hospital (Other), Tianjin Medical University General Hospital (Other), The Affiliated Hospital of Inner Mongolia Medical University (Other), The First Hospital of Qinhuangdao (Other)

10,385

Enrollment

Locations

43.2

Actual Duration (Months)

1038.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COPD FEV1	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 Design

Study Type:

Observational

Actual Enrollment :

10385 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Mar 3, 2018

Actual Primary Completion Date :

Dec 31, 2020

Actual Study Completion Date :

Oct 9, 2021

Outcome Measures

Primary Outcome Measures

The incidence of COPD in the second and fourth year and the association between incidence of COPD and rapid decline of FEV1. [4 years]
FEV1/FVC(forced vital capacity)<70% (after bronchial dilation test);Detect the decline of FEV1(%)by Vitalograph COPD6.

Secondary Outcome Measures

The association between incidence of COPD and the air pollution level in different provinces in China. [4 years]
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.
The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease. [4 years]
Record comorbidity condition data of human subjects, and then analyze the correlation between the COPD incidence and different comorbidity condition.
The mean decline rate of FEV1 [4 years]
Monitor pulmonary function decline in the second and the fourth year, then calculate the mean decline value.
The association between decline rate of FEV1 and air pollution level [4 years]
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.
The correlation between the incidence of COPD and serum IL-6 level. [4 years]
Detect the serum IL-6 levels(ng/L), then analyze the correlation between the IL-6 levels and COPD incidence.
The correlation between the incidence of COPD and serum hs-CRP level. [4 years]
Detect the serum hs-CRP levels(ng/L), then analyze the correlation between the hs-CRP levels and COPD incidence.
The association between the pH value of EBC and COPD incidence. [4 years]
Detect the EBC pH value, then analyze the correlation between the EBC pH value and COPD incidence.
The association between serum miR-23a level and COPD incidence. [4 years]
Detect the serum miR-23a level, then analyze the correlation between serum miR-23a level and COPD incidence.
The association between incidence of COPD and other factors. [4 years]
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)).

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Peking University First Hospital	Beijing	Beijing	China	100034
2	The First Hospital of Qinhuangdao	Qinhuangdao	Hebei	China
3	The Second Hospital of Hebei Medical University	Shijiazhuang	Hebei	China
4	Henan Provincial People's Hospital	Zhengzhou	Henan	China
5	The Affiliated Hospital of Inner Mongolia Medical University	Hohhot	Inner Mongolia	China
6	The Second Hospital of Jilin University	Changchun	Jilin	China
7	Shandong Provincial Hospital Affiliated to Shandong University	Jinan	Shandong	China
8	The First Affiliated Hospital of Shanxi Medical University	Taiyuan	Shanxi	China
9	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China
10	Tianjin Medical University General Hospital	Tianjin	Tianjin	China

Investigators

Study Chair: Guangfa Wang, MD, Peking University First Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Guangfa Wang, Head of Respiratory and critical Medicine, Principal Investigator, Clinical Professor, Peking University First Hospital

ClinicalTrials.gov Identifier:

NCT03532893

Other Study ID Numbers:

2017YFC1309500-1

First Posted:

May 22, 2018

Last Update Posted:

Mar 29, 2022

Last Verified:

Mar 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Guangfa Wang, Head of Respiratory and critical Medicine, Principal Investigator, Clinical Professor, Peking University First Hospital

COPD incidence

Decline in FEV1

Inflammatory biomarkers

EBC

microRNA-23a