Predictive Value of Inflammatory Biomarkers and FEV1 for COPD

NCT03532893 | Completed DMC

• 1 other identifier: 2017YFC1309500-1
• Study Type: observational
• Target: 10,385
• Locations: 1 country
• Sites: 10

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.

Conditions

COPD; FEV1

Keywords

COPD incidence; Decline in FEV1; Inflammatory biomarkers; EBC; microRNA-23a

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The association between incidence of COPD and the air pollution level in different provinces in China.

  4 years

• The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease.

  4 years

• The mean decline rate of FEV1

  4 years

• The association between decline rate of FEV1 and air pollution level

  4 years

• The correlation between the incidence of COPD and serum IL-6 level.

  4 years

Interventions

No intervention OTHER

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.

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (10)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

Location

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Location

The Second Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Location

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Location

The Affiliated Hospital of Inner Mongolia Medical University

Hohhot, Inner Mongolia, China

Location

The Second Hospital of Jilin University

Changchun, Jilin, China

Location

Shandong Provincial Hospital Affiliated to Shandong University

Jinan, Shandong, China

Location

The First Affiliated Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

The First Affiliated Hospital of Xi'an Jiaotong University

Xi’an, Shanxi, China

Location

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Location

Related Publications (4)

• 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.

  PMID: 38479820 DERIVED

• 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.

  PMID: 38197225 DERIVED

• 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.

  PMID: 37231445 DERIVED

• 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.

  PMID: 31824147 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

plasma，whole blood，exhaled breath condensate

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangfa Wang, MD

  Peking University First Hospital

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Respiratory and critical Medicine, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: March 29, 2018
• First Posted: May 22, 2018
• Study Start: March 3, 2018
• Primary Completion: December 31, 2020
• Study Completion: October 9, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)