Observational study on early signs of COPD in patients with preserved lung function

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

This study is trying to find early signs of COPD in people with normal lung function by looking at their biological samples and lung images over three years.

Quick facts

• Study type: Observational
• Enrollment: 2000 (estimated)
• Ages: 20 Years to 75 Years
• Sex: All
• Sponsor: Peking University First Hospital (Academic / other)
• Locations: 6 sites (Beijing, Beijing Municipality and 5 other locations)
• Trial ID: NCT06340295 on ClinicalTrials.gov

What this trial studies

This study focuses on individuals with preserved ratio impaired spirometry (PRISm), which may be an early stage of chronic obstructive pulmonary disease (COPD). It aims to establish a prospective cohort to analyze various biological samples, including blood, exhaled breath condensate, and urine, to investigate inflammatory factors, metabolomics, proteomics, and microbiome characteristics. Additionally, chest HRCT imaging will be performed to gather indicators related to lung health, with participants undergoing a three-year dynamic follow-up to observe the evolution of their condition. The goal is to enhance understanding of the early pathophysiological mechanisms of COPD and identify potential early intervention strategies.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 20 to 75 with preserved lung function but showing early signs of respiratory issues.

Not a fit: Patients with confirmed COPD or other significant respiratory diseases will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to earlier detection and intervention strategies for COPD, potentially improving patient outcomes.

How similar studies have performed: While the approach of studying PRISm is relatively novel, similar studies have shown promise in understanding early COPD mechanisms.

Eligibility criteria

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;

Where this trial is running

Beijing, Beijing Municipality and 5 other locations

• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• Peking University First Hospital — Beijing, Beijing Municipality, China (Recruiting)
• The First Hospital of Qinhuangdao — Qinhuangdao, Hebei, China (Recruiting)
• Tianjin Medical University General Hospital — Tianjin, Tianjin Municipality, China (Recruiting)
• Shandong Provincial Hospital Affiliated to Shandong University — Jing’an, China (Recruiting)
• Shanxi Bethune Hospital — Taiyuan, China (Recruiting)

Study contacts

• Study coordinator: Jiping Liao, MD.

Conditions COPD; PRISm; Imaging omics; Metabolomics; proteomics