Actively Recruiting
A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
Led by Peking University First Hospital · Updated on 2024-04-01
2000
Participants Needed
6
Research Sites
143 weeks
Total Duration
On this page
Sponsors
P
Peking University First Hospital
Lead Sponsor
S
Shanxi Bethune Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 20 and 75 years old, any gender
- Pulmonary function test after bronchodilator: FEV1/FVC ≥ 70% and FEV1 < 80% of predicted value
- Agree to join the study and sign informed consent
- Able to follow the study procedures
You will not qualify if you...
- Confirmed diagnosis of COPD, bronchial asthma, bronchiectasis, interstitial lung disease, occupational lung disease, tuberculosis, pulmonary vascular disease, central airway stenosis, or other respiratory diseases
- Previous lobectomy or lung transplantation
- Serious underlying diseases such as severe mental illness, mental retardation, neurological diseases, cancer, chronic liver disease, heart failure, autoimmune disease, or chronic kidney disease
- Severe pleural disease or lesions of the sternum or ribs
- Active tuberculosis or currently receiving anti-tuberculosis treatment
- Pregnancy or breastfeeding
- Unable to comply with long-term follow-up or poor compliance
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
2
Peking University First Hospital
Beijing, Beijing Municipality, China, 100034
Actively Recruiting
3
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China
Actively Recruiting
4
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China
Actively Recruiting
5
Shandong Provincial Hospital Affiliated to Shandong University
Jing’an, China
Actively Recruiting
6
Shanxi Bethune Hospital
Taiyuan, China
Actively Recruiting
Research Team
J
Jiping Liao, MD.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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