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

NCT ID: NCT06340295

Last Updated: 2024-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-09-01

Study Completion Date

2026-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

COPD

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

new-onset COPD group

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

Intervention Type OTHER

Continuous PRISm group

After bronchodilator inhalation, FEV1/FVC≥70% and the percentage of FEV1pred%\<80% during 3 years of follow-up

Intervention Type OTHER

PRISm to normal group

After bronchodilator inhalation, FEV1/FVC≥0.7 and FEV1pred% ≥80% during 3 years of follow-up

Intervention Type OTHER

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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;
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanxi Bethune Hospital

OTHER

Sponsor Role collaborator

First Affiliated Hospital Xi'an Jiaotong University

OTHER

Sponsor Role collaborator

Tianjin Medical University General Hospital

OTHER

Sponsor Role collaborator

The First Hospital of Qinhuangdao

OTHER_GOV

Sponsor Role collaborator

Shandong Provincial Hospital

OTHER_GOV

Sponsor Role collaborator

Second Hospital of Jilin University

OTHER

Sponsor Role collaborator

People's Hospital of Xinjiang Uygur Autonomous Region

OTHER

Sponsor Role collaborator

MinDong Hospital of Ningde City

UNKNOWN

Sponsor Role collaborator

Peking University First Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guangfa Wang, MD.

Role: STUDY_CHAIR

Peking University First Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Peking University First Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The First Hospital of Qinhuangdao

Qinhuangdao, Hebei, China

Site Status RECRUITING

Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Shandong Provincial Hospital Affiliated to Shandong University

Jing'an, , China

Site Status RECRUITING

Shanxi Bethune Hospital

Taiyuan, , China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jiping Liao, MD.

Role: CONTACT

13521714181

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jiping Liao, MD.

Role: primary

13521714181

Chunbo Zhang

Role: backup

13086645758

Guangfa Wang, MD

Role: primary

13810644029

Jiping Liao, MD

Role: backup

13521714181

Hua Qiao, MD

Role: primary

13780358298

Lixia Dong, MD

Role: primary

13001385918

Jian Sun, MD

Role: primary

Ruiying Wang, MD

Role: primary

+86 13903436432

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023313

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.