Clinical trial NCT06340295: A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
Official title: A Multicenter, Prospective Cohort Study of Preserved Ratio Impaired Spirometry(PRISm) in a Population
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COPD
Keywords: PRISm
COPD
Imaging omics
Metabolomics
proteomics
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
Collaborators: name: Shanxi Bethune Hospital
name: First Affiliated Hospital Xi'an Jiaotong University
name: Tianjin Medical University General Hospital
name: The First Hospital of Qinhuangdao
name: Shandong Provincial Hospital
name: Second Hospital of Jilin University
name: People's Hospital of Xinjiang Uygur Autonomous Region
name: MinDong Hospital of Ningde City
First posted: 2024-04-01
Enrollment: 2000
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects are 1430 PRISm people from the PIFCOPD cohort in our center and 600 newly enrolled PRISm people in this study, totaling approximately 2000 PRISm people.

Brief 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 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;

Primary outcomes:
measure: The number and proportion of newly diagnosed COPD
timeFrame: the third year of follow-up
Secondary outcomes:
measure: The number and proportion of continuous PRISm population
timeFrame: the third year of follow-up
measure: The number and proportion of PRISm to normal population
timeFrame: the third year of follow-up
measure: Emerging diseases
timeFrame: the third year of follow-up
measure: Death and cause of death
timeFrame: the third year of follow-up
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University First Hospital
state: Beijing
city: Qinhuangdao
country: China
facility: The First Hospital of Qinhuangdao
state: Hebei
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
state: Tianjin
city: Jing'an
country: China
facility: Shandong Provincial Hospital Affiliated to Shandong University
city: Taiyuan
country: China
facility: Shanxi Bethune Hospital
Study officials:
affiliation: Peking University First Hospital
name: Guangfa Wang, MD.
role: STUDY_CHAIR
References: