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

Last updated: March 25, 2024
Sponsor: Peking University First Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06340295
2023313
  • Ages 20-75
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

Exclusion Criteria:

    1. Confirmed chronic obstructive pulmonary disease, bronchial asthma, bronchiectasis,interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vasculardisease, central airway stenosis and other confirmed respiratory diseases.
  1. Have undergone lobectomy and/or lung transplantation; 3) complicated with seriousunderlying 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 diseaseand/or lesions of the sternum or ribs; 5) Have active tuberculosis or are receivinganti-tuberculosis treatment; 6) Pregnancy or lactation; 7) Can not be followed up fora long time or poor compliance;

Study Design

Total Participants: 2000
Study Start date:
September 01, 2023
Estimated Completion Date:
May 31, 2026

Connect with a study center

  • Peking University First Hospital

    Beijing, Beijing 100034
    China

    Active - Recruiting

  • The First Hospital of Qinhuangdao

    Qinhuangdao, Hebei
    China

    Active - Recruiting

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin
    China

    Active - Recruiting

  • Shandong Provincial Hospital Affiliated to Shandong University

    Jing'an,
    China

    Active - Recruiting

  • Shanxi Bethune Hospital

    Taiyuan,
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.