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Predictive Value of Inflammatory Biomarkers and FEV1 for COPD (PIFCOPD)

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ClinicalTrials.gov Identifier: NCT03532893
Recruitment Status : Unknown
Verified September 2018 by Guangfa Wang, Peking University First Hospital.
Recruitment status was:  Recruiting
First Posted : May 22, 2018
Last Update Posted : September 25, 2018
Sponsor:
Collaborators:
The Second Hospital of Hebei Medical University
Henan Provincial People's Hospital
Second Hospital of Jilin University
First Affiliated Hospital Xi'an Jiaotong University
Shandong Provincial Hospital
Shanxi Dayi Hospital
Tianjin Medical University General Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The First Hospital of Qinhuangdao
Information provided by (Responsible Party):
Guangfa Wang, Peking University First Hospital

Study Description
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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
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
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Study Type : Observational
Estimated Enrollment : 10000 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 : April 3, 2018
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Groups and Cohorts
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Intervention Details:
  • 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.

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


Secondary Outcome Measures :
  1. The association between incidence of COPD and the air pollution level in different provinces in China. [ Time Frame: 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.

  2. The association between incidence of COPD and different comorbidity condition, such as metabolic syndrome, cardiovascular disease. [ Time Frame: 4 years ]
    Record comorbidity condition data of human subjects, and then analyze the correlation between the COPD incidence and different comorbidity condition.

  3. The mean decline rate of FEV1 [ Time Frame: 4 years ]
    Monitor pulmonary function decline in the second and the fourth year, then calculate the mean decline value.

  4. The association between decline rate of FEV1 and air pollution level [ Time Frame: 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.

  5. The correlation between the incidence of COPD and serum IL-6 level. [ Time Frame: 4 years ]
    Detect the serum IL-6 levels(ng/L), then analyze the correlation between the IL-6 levels and COPD incidence.

  6. The correlation between the incidence of COPD and serum hs-CRP level. [ Time Frame: 4 years ]
    Detect the serum hs-CRP levels(ng/L), then analyze the correlation between the hs-CRP levels and COPD incidence.

  7. The association between the pH value of EBC and COPD incidence. [ Time Frame: 4 years ]
    Detect the EBC pH value, then analyze the correlation between the EBC pH value and COPD incidence.

  8. The association between serum miR-23a level and COPD incidence. [ Time Frame: 4 years ]
    Detect the serum miR-23a level, then analyze the correlation between serum miR-23a level and COPD incidence.

  9. The association between incidence of COPD and other factors. [ Time Frame: 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)).


Biospecimen Retention:   Samples With DNA
plasma，whole blood，exhaled breath condensate

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03532893


Contacts
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Contact: Guangfa Wang, MD +86 13810644029 wangguangfa@hotmail.com
Contact: Jiping Liao, MD +86 13521714181 colorfulwing01@163.com

Locations
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China, Beijing
Peking University First Hospital Not yet recruiting
Beijing, Beijing, China, 100034
Contact: Guangfa Wang, MD    13810644029    wangguangfa@hotmail.com   
Contact: Jiping Liao, MD    13521714181    colorfulwing01@163.com   
Sub-Investigator: Yunxia Wang, PhD         
Sub-Investigator: Yijue Zhong, PhD         
Sub-Investigator: Chao Sun, PhD         
China, Hebei
The First Hospital of Qinhuangdao Recruiting
Qinhuangdao, Hebei, China
Contact: Hua Qiao, MD    13780358298    qh1202@163.com   
The Second Hospital of Hebei Medical University Not yet recruiting
Shijiazhuang, Hebei, China
Contact: Xixin Yan, MD    15803210959    xi_xin_yan@163.com   
China, Henan
Henan Provincial People's Hospital Not yet recruiting
Zhengzhou, Henan, China
Contact: Limin Zhao, MD    18538297806    zlm9898@126.com   
China, Inner Mongolia
The Affiliated Hospital of Inner Mongolia Medical University Recruiting
Hohhot, Inner Mongolia, China
Contact: Xiuhua Fu, MD    13947142625    fuxiuhua555@sohu.com   
China, Jilin
The Second Hospital of Jilin University Not yet recruiting
Changchun, Jilin, China
Contact: Jinzhi Yin, MD    13504409660    yjz6437@163.com   
China, Shandong
Shandong Provincial Hospital Affiliated to Shandong University Not yet recruiting
Jinan, Shandong, China
Contact: Shujuan Jiang, MD    15168887199    shujuan-jiang@163.com   
China, Shanxi
The First Affiliated Hospital of Shanxi Medical University Not yet recruiting
Taiyuan, Shanxi, China
Contact: Ruiying Wang, MD    13903436432    wry0526@163.com   
The First Affiliated Hospital of Xi'an Jiaotong University Not yet recruiting
Xi'an, Shanxi, China
Contact: Xiaomin Dang, MD    18991232795    dxming112@163.com   
China, Tianjin
Tianjin Medical University General Hospital Not yet recruiting
Tianjin, Tianjin, China
Contact: Lixia Dong, MD    13001385918    luckydonglixia@163.com   
Sponsors and Collaborators
Peking University First Hospital
The Second Hospital of Hebei Medical University
Henan Provincial People's Hospital
Second Hospital of Jilin University
First Affiliated Hospital Xi'an Jiaotong University
Shandong Provincial Hospital
Shanxi Dayi Hospital
Tianjin Medical University General Hospital
The Affiliated Hospital of Inner Mongolia Medical University
The First Hospital of Qinhuangdao
Investigators
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Study Chair: Guangfa Wang, MD Peking University First Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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    Key Record Dates
Last Update Posted: September 25, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Guangfa Wang, Peking University First Hospital:
COPD incidence
Decline in FEV1
Inflammatory biomarkers
EBC
microRNA-23a