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COPDPIFCOPDNCT03532893

Predictive Value of Inflammatory Biomarkers and FEV1 for COPD

An observational study of COPD and FEV1, run by Peking University First Hospital at 10 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 40 to 75 yearsHealthy volunteers can take part
Conditions the study is for
COPD, FEV1
How many people
10,385 participants
Where
10 sitesChina
Study dates
3 Mar 2018to 9 Oct 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 75 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: A total of 10,000 subjects aged 40～75 without history of lung disease will be recruited and followed for 3 years.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

10 sites in 1 country.

10 sites in 1 country

China10 sites

  • Peking University First Hospital

    Beijing, Beijing Municipality, 100034

  • The Second Hospital of Jilin University

    Changchun, Jilin

  • The Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia

  • Shandong Provincial Hospital Affiliated to Shandong University

    Jinan, Shandong

  • The First Hospital of Qinhuangdao

    Qinhuangdao, Hebei

  • The Second Hospital of Hebei Medical University

    Shijiazhuang, Hebei

  • The First Affiliated Hospital of Shanxi Medical University

    Taiyuan, Shanxi

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • Henan Provincial People's Hospital

    Zhengzhou, Henan

Other trials in China

About this study

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

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.

Read the 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
Being tested
No intervention
Keywords
COPD incidence, Decline in FEV1, Inflammatory biomarkers, EBC, microRNA-23a
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • No interventionOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 4 years

Secondary outcomes (9)

  1. 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.

    Measured: 4 years

  2. 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.

    Measured: 4 years

  3. The mean decline rate of FEV1

    Monitor pulmonary function decline in the second and the fourth year, then calculate the mean decline value.

    Measured: 4 years

  4. 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.

    Measured: 4 years

  5. 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.

    Measured: 4 years

  6. 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.

    Measured: 4 years

  7. 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.

    Measured: 4 years

  8. 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.

    Measured: 4 years

  9. 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)).

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 May 2018
  2. Study start3 Mar 2018
  3. Primary completion31 Dec 2020
  4. Study completion9 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
10,385 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03532893
Sponsor's protocol ID
2017YFC1309500-1
Acronym
PIFCOPD
Status last verified
Mar 2022
First submitted
29 Mar 2018
Last updated
29 Mar 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38479820

  • 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.

    PubMed 38197225

  • 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.

    PubMed 37231445

  • 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.

    PubMed 31824147

Questions about this trial

What is this clinical trial studying?

An observational study of COPD and FEV1, run by Peking University First Hospital at 10 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03532893, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.

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