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

COPD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06340295
• Other study ID #: 2023313
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: October 2023
• Source: Peking University First Hospital
• Contact: Jiping Liao, MD.
• Phone: 13521714181
• Email: colorfulwing01[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 75 Years

Eligibility

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;

Related Conditions & MeSH terms

• COPD

Locations

Country	Name	City	State
China	Peking University First Hospital	Beijing	Beijing
China	Peking University First Hospital	Beijing	Beijing
China	Shandong Provincial Hospital Affiliated to Shandong University	Jing'an
China	The First Hospital of Qinhuangdao	Qinhuangdao	Hebei
China	Shanxi Bethune Hospital	Taiyuan
China	Tianjin Medical University General Hospital	Tianjin	Tianjin

Sponsors (9)

Lead Sponsor	Collaborator
Peking University First Hospital	First Affiliated Hospital Xi'an Jiaotong University, MinDong Hospital of Ningde City, People's Hospital of Xinjiang Uygur Autonomous Region, Second Hospital of Jilin University, Shandong Provincial Hospital, Shanxi Bethune Hospital, The First Hospital of Qinhuangdao, Tianjin Medical University General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	The number and proportion of continuous PRISm population	After bronchodilator inhalation, FEV1/FVC=70% and the percentage of FEV1pred%<80% during 3 years of follow-up	the third year of follow-up
Secondary	The number and proportion of PRISm to normal population	After bronchodilator inhalation, FEV1/FVC=0.7 and FEV1pred% =80% during 3 years of follow-up	the third year of follow-up
Secondary	Emerging diseases	Emerging diseases: non-COPD lung diseases (bronchial asthma, ILD), OSA, cardiovascular diseases (such as coronary heart disease, hypertension, etc.), endocrine diseases (such as diabetes), cerebrovascular diseases, digestive diseases, chronic kidney diseases, etc.	the third year of follow-up
Secondary	Death and cause of death	Death and cause of death	the third year of follow-up