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

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 20
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Peking University First Hospital
RECRUITING
Beijing
Peking University First Hospital
RECRUITING
Beijing
Shandong Provincial Hospital Affiliated to Shandong University
RECRUITING
Jing'an
The First Hospital of Qinhuangdao
RECRUITING
Qinhuangdao
Shanxi Bethune Hospital
RECRUITING
Taiyuan
Tianjin Medical University General Hospital
RECRUITING
Tianjin
Contact Information
Primary
Jiping Liao, MD.
colorfulwing01@163.com
13521714181
Time Frame
Start Date: 2023-09-01
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 2000
Treatments
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
Sponsors
Collaborators: Second Hospital of Jilin University, MinDong Hospital of Ningde City, First Affiliated Hospital Xi'an Jiaotong University, Shanxi Bethune Hospital, Tianjin Medical University General Hospital, The First Hospital of Qinhuangdao, People's Hospital of Xinjiang Uygur Autonomous Region, Shandong Provincial Hospital
Leads: Peking University First Hospital

This content was sourced from clinicaltrials.gov

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