A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population

March 25, 2024 updated by: Peking University First Hospital
Chronic obstructive pulmonary disease (COPD) is the most common chronic tract disease and the third leading cause of death worldwide. The treatment effect of COPD is poor, and the disease is progressive, resulting in a serious disease burden. The key reason is that early recognition is difficult and the early pathophysiological mechanism is unclear, which leads to the difficulty of early intervention.PRISm is likely to be the precursor stage of COPD, which may provide an important research object for the study of pathophysiological characteristics, inflammation and immunomodulatory mechanisms of early COPD, and may also become a new entry point for early intervention of COPD. This study attempts to establish a PRISm prospective cohort，and collects blood, EBC and urine for analysis of inflammatory factors, metabolomics, proteomics and microbiome, and performs chest HRCT to obtain imaging indicators, and conducts 3-year dynamic follow-up observation to study the evolution characteristics of pulmonary function and the incidence of COPD in the PRISm cohort. To compare the differences in imaging, inflammatory factors, metabolomics, proteomics and microbiome among the three PRISm groups, and establish a risk prediction model for progression to COPD through PRISm. It lays a foundation for understanding the characteristics of COPD at an earlier stage and exploring new early warning indicators.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Jing'an, China
        • Recruiting
        • Shandong Provincial Hospital Affiliated to Shandong University
        • Contact:
      • Taiyuan, China
        • Recruiting
        • Shanxi Bethune Hospital
        • Contact:
    • Beijing
      • Beijing, Beijing, China, 100034
        • Recruiting
        • Peking University First Hospital
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Yunxia Wang, PhD
        • Sub-Investigator:
          • Yijue Zhong, PhD
        • Sub-Investigator:
          • Chao Sun, PhD
    • Hebei
      • Qinhuangdao, Hebei, China
        • Recruiting
        • The First Hospital of Qinhuangdao
        • Contact:
    • Tianjin
      • Tianjin, Tianjin, China
        • Recruiting
        • Tianjin Medical University General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The subjects are 1430 PRISm people from the PIFCOPD cohort in our center and 600 newly enrolled PRISm people in this study, totaling approximately 2000 PRISm people.

Description

Inclusion Criteria:

  • 1) Age range from 20 to 75 years old, regardless of gender; 2) Pulmonary function test: After inhaling bronchodilators, FEV1/FVC ≥ 70%, and FEV1<80% of the expected value; 3) Agree to enter this research project and sign an informed consent form 4) Able to comply with research protocols.

Exclusion Criteria:

  • 1) Confirmed chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis, interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vascular disease, central airway stenosis and other confirmed respiratory diseases.

    2) Have undergone lobectomy and/or lung transplantation; 3) complicated with serious underlying diseases (including serious mental illness, mental retardation, neurological disease, malignant tumor, chronic liver disease, heart failure, autoimmune disease, chronic kidney disease); 4) accompanied by severe pleural disease and/or lesions of the sternum or ribs; 5) Have active tuberculosis or are receiving anti-tuberculosis treatment; 6) Pregnancy or lactation; 7) Can not be followed up for a long time or poor compliance;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
new-onset COPD group
FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up
Continuous PRISm group
After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%<80% during 3 years of follow-up
PRISm to normal group
After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number and proportion of newly diagnosed COPD
Time Frame: the third year of follow-up
FEV1/FVC<0.7 after bronchodilator inhalation during 3 years of follow-up
the third year of follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The number and proportion of continuous PRISm population
Time Frame: the third year of follow-up
After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%<80% during 3 years of follow-up
the third year of follow-up
The number and proportion of PRISm to normal population
Time Frame: the third year of follow-up
After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up
the third year of follow-up
Emerging diseases
Time Frame: the third year of follow-up
Emerging diseases: non-COPD lung diseases (bronchial asthma, ILD), OSA, cardiovascular diseases (such as coronary heart disease, hypertension, etc.), endocrine diseases (such as diabetes), cerebrovascular diseases, digestive diseases, chronic kidney diseases, etc.
the third year of follow-up
Death and cause of death
Time Frame: the third year of follow-up
Death and cause of death
the third year of follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking University First Hospital

Collaborators

First Affiliated Hospital Xi'an Jiaotong University
Shandong Provincial Hospital
People's Hospital of Xinjiang Uygur Autonomous Region
Tianjin Medical University General Hospital
Second Hospital of Jilin University
The First Hospital of Qinhuangdao
Shanxi Bethune Hospital
MinDong Hospital of Ningde City

Investigators

  • Study Chair: Guangfa Wang, MD., Peking University First Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2023

Primary Completion (Estimated)

May 31, 2026

Study Completion (Estimated)

May 31, 2026

Study Registration Dates

First Submitted

March 25, 2024

First Submitted That Met QC Criteria

March 25, 2024

First Posted (Actual)

April 1, 2024

Study Record Updates

Last Update Posted (Actual)

April 1, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2023313

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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