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

NCT06340295 | Recruiting DMC

• 1 other identifier: 2023313
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 6

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.

Conditions

COPD

Keywords

PRISm; COPD; Imaging omics; Metabolomics; proteomics

Outcome Measures

Primary Outcomes (1)

• The number and proportion of newly diagnosed COPD

  FEV1/FVC\<0.7 after bronchodilator inhalation during 3 years of follow-up

  the third year of follow-up

Secondary Outcomes (4)

• The number and proportion of continuous PRISm population

  the third year of follow-up

• The number and proportion of PRISm to normal population

  the third year of follow-up

• Emerging diseases

  the third year of follow-up

• Death and cause of death

  the third year of follow-up

Study Arms (3)

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

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \) 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.

You may not qualify if:

• \) 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.
• \) 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;

Sponsors & Collaborators

• Peking University First Hospital: lead
• Shanxi Bethune Hospital: collaborator
• First Affiliated Hospital Xi'an Jiaotong University: collaborator
• Tianjin Medical University General Hospital: collaborator
• The First Hospital of Qinhuangdao: collaborator
• Shandong Provincial Hospital: collaborator
• Second Hospital of Jilin University: collaborator
• People's Hospital of Xinjiang Uygur Autonomous Region: collaborator
• MinDong Hospital of Ningde City: collaborator

Study Sites (6)

Peking University First Hospital

Beijing, Beijing Municipality, 100034, China

RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, 100034, 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

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guangfa Wang, MD.

  Peking University First Hospital

  STUDY CHAIR

Central Study Contacts

Jiping Liao, MD.

CONTACT

13521714181; colorfulwing01@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2024
• First Posted: April 1, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: April 1, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (6)