Predictive Value of Inflammatory Biomarkers and FEV1 for COPD

NCT ID: NCT03532893

Last Updated: 2022-03-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 10385 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-03-03
• Study Completion Date: 2021-10-09

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.

Conditions

COPD; FEV1

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Second Hospital of Hebei Medical University

OTHER

Sponsor Role: collaborator

Henan Provincial People's Hospital

OTHER

Sponsor Role: collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role: collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role: collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role: collaborator

Shanxi Dayi Hospital

OTHER

Sponsor Role: collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role: collaborator

The Affiliated Hospital of Inner Mongolia Medical University

OTHER

Sponsor Role: collaborator

The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role: collaborator

Peking University First Hospital

OTHER

Sponsor Role: lead

Responsible Party

Guangfa Wang

Head of Respiratory and critical Medicine, Principal Investigator, Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Guangfa Wang, MD

Role: STUDY_CHAIR

Peking University First Hospital

Locations

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

The Second Hospital of Jilin University

Changchun, Jilin, China

Shandong Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, China

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Countries

China

References

Yang X, Liao J, Zhu S, Zhang C, Ma X, Zhang C, Wang Y, Sun K, Wang G. Association of high-sensitivity CRP and FEV1%pred: a study on non-pulmonary disease in a population in Beijing, China. BMJ Open Respir Res. 2024 Mar 13;11(1):e001699. doi: 10.1136/bmjresp-2023-001699.

Reference Type: DERIVED

PMID: 38479820 (View on PubMed)

Ma X, Zhang C, Wang Y, Yu K, Jin Z, Zhang C, Ma J, Liao J, Wang G. Correlation of morning dry mouth with clinical features of OSA in a community population: a cross-sectional study. Postgrad Med. 2024 Jan;136(1):30-35. doi: 10.1080/00325481.2024.2303972. Epub 2024 Jan 14.

Reference Type: DERIVED

PMID: 38197225 (View on PubMed)

Wei S, Liao J, Xue T, Yu K, Fu X, Wang R, Dang X, Zhang C, Qiao H, Jiang S, Xiao J, Dong L, Yin J, Yan X, Jia W, Zhang G, Chen R, Zhou B, Song B, Li J, Yin M, Zhang L, Xie L, Dong S, Sun J, Gao P, Miao B, Li W, He L, Ning Q, Zhao L, Liu H, Cao H, Wang G. Ambient fine particulate matter and allergic symptoms in the middle-aged and elderly population: results from the PIFCOPD study. Respir Res. 2023 May 25;24(1):139. doi: 10.1186/s12931-023-02433-2.

Reference Type: DERIVED

PMID: 37231445 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 31824147 (View on PubMed)

Other Identifiers

2017YFC1309500-1

Identifier Type: -

Identifier Source: org_study_id