RecruitingNCT06340295

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


Sponsor

Peking University First Hospital

Enrollment

2,000 participants

Start Date

Sep 1, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 20 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study follows people with a lung function pattern called PRISm (Preserved Ratio Impaired Spirometry) — where breathing tests show reduced air volume even though the ratio between measurements is normal. PRISm may be an early sign of lung disease. The study tracks what happens to these individuals over time. **You may be eligible if...** - You are 20 to 75 years old - Your lung function test (after using a bronchodilator inhaler) shows: FEV1/FVC ratio ≥ 70% AND FEV1 below 80% of the expected value - You agree to participate and can comply with the study protocol **You may NOT be eligible if...** - You have already been diagnosed with COPD, asthma, bronchiectasis, interstitial lung disease, tuberculosis, or other known respiratory diseases - You have had part of a lung removed or a lung transplant - You have serious underlying conditions such as severe mental illness, cancer, heart failure, autoimmune disease, or advanced kidney or liver disease - You are pregnant or breastfeeding - You are unable to attend long-term follow-up visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHER

Locations(6)

Peking University First Hospital

Beijing, Beijing Municipality, China

Peking University First Hospital

Beijing, Beijing Municipality, China

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Shandong Provincial Hospital Affiliated to Shandong University

Jing’an, China

Shanxi Bethune Hospital

Taiyuan, China

View Full Details on ClinicalTrials.gov

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NCT06340295


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