Predictive Value of Inflammatory Biomarkers and FEV1 for COPD

COPD Clinical Trial

— PIFCOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03532893
• Other study ID #: 2017YFC1309500-1
• Status: Completed
• Start date: March 3, 2018
• Est. completion date: October 9, 2021

Study information

• Verified date: March 2022
• Source: Peking University First Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10385
• Est. completion date: October 9, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• COPD
• FEV1

Intervention

Other:
• No intervention
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.

Locations

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

Sponsors (10)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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