Clinical trial NCT03532893: Predictive Value of Inflammatory Biomarkers and FEV1 for COPD
Official title: Predictive Value of Combining Inflammatory Biomarkers and Rapid Decline of FEV1 for COPD in Chinese Population - a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COPD
FEV1
Keywords: COPD incidence
Decline in FEV1
Inflammatory biomarkers
EBC
microRNA-23a
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: The Second Hospital of Hebei Medical University
name: Henan Provincial People's Hospital
name: Second Hospital of Jilin University
name: First Affiliated Hospital Xi'an Jiaotong University
name: Shandong Provincial Hospital
name: Shanxi Dayi Hospital
name: Tianjin Medical University General Hospital
name: The Affiliated Hospital of Inner Mongolia Medical University
name: The First Hospital of Qinhuangdao
First posted: 2018-05-22
Enrollment: 10385
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: The incidence of COPD in the second and fourth year and the association between incidence of COPD and rapid decline of FEV1.
timeFrame: 4 years
Secondary outcomes:
measure: The association between incidence of COPD and the air pollution level in different provinces in China.
timeFrame: 4 years
measure: The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease.
timeFrame: 4 years
measure: The mean decline rate of FEV1
timeFrame: 4 years
measure: The association between decline rate of FEV1 and air pollution level
timeFrame: 4 years
measure: The correlation between the incidence of COPD and serum IL-6 level.
timeFrame: 4 years
measure: The correlation between the incidence of COPD and serum hs-CRP level.
timeFrame: 4 years
measure: The association between the pH value of EBC and COPD incidence.
timeFrame: 4 years
measure: The association between serum miR-23a level and COPD incidence.
timeFrame: 4 years
measure: The association between incidence of COPD and other factors.
timeFrame: 4 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Qinhuangdao
country: China
facility: The First Hospital of Qinhuangdao
state: Hebei
city: Shijiazhuang
country: China
facility: The Second Hospital of Hebei Medical University
state: Hebei
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Hohhot
country: China
facility: The Affiliated Hospital of Inner Mongolia Medical University
state: Inner Mongolia
city: Changchun
country: China
facility: The Second Hospital of Jilin University
state: Jilin
city: Jinan
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong University
state: Shandong
city: Taiyuan
country: China
facility: The First Affiliated Hospital of Shanxi Medical University
state: Shanxi
city: Xi'an
country: China
facility: The First Affiliated Hospital of Xi'an Jiaotong University
state: Shanxi
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
Study officials:
affiliation: Peking University First Hospital
name: Guangfa Wang, MD
role: STUDY_CHAIR
References:
citation: 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.