Early COPD for China Pulmonary Health Study Stage II

Obstructive Pulmonary Disease Clinical Trial

— EC-CPHS  

Official title:

A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05028985
• Other study ID #: 82090011
• Status: Recruiting
• Start date: January 1, 2021
• Est. completion date: December 2025

Study information

• Verified date: August 2021
• Source: China-Japan Friendship Hospital
• Contact: Chen Wang
• Phone: +86 010 69156477
• Email: cyh-birm[@]263.net
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Discovery of the pathogenesis and targets in the progression of early chronic obstructive pulmonary disease

Description:

This project is aimed to investigate and explore the heterogeneity during the progression of Chronic Obstructive Pulmonary Disease (COPD) in the early stage, utilizing the large-scale population cohort databases (including "China Pulmonary Health study", "The Cohort Study for Chronic Obstructive Pulmonary Disease in China" and "Acute Exacerbation of COPD Patient Registry in China" ), biological sample libraries(including blood, sputum, expiratory air, bronchoalveolar lavage fluid(BALF), and lung tissue from COPD patients with different stages and phenotypes), and multi-omics sequencing (including scRNA-seq, metabolomics, proteomics, and metagenome). We propose to establish a new standard for COPD stages and subtypes. By analyzing and mining the multi-omics data, it is expected to illustrate the association between clinical phenotype and molecular, cellular and tissue heterogeneities, thus reveal biomarkers related to the progression, clinical phenotypes, and prognosis of early-stage COPD disease.In addition, we will construct different types and stages of COPD animal models for further mechanism studies, such as the different pathogenic factors, innate and adaptive immunity, and the airway microbial ecosystem, so that we can discovered more potential therapeutic target for early-stage COPD. This project can bring a new insight and scientific evidence for COPD treatment.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• younger than 50 years

• smoking more than 10 pack-years

• early airflow limitation(post-bronchodilator FEV1/FVC< lower limit of normal)

Exclusion Criteria:

• cancer

• other respiratory diseases

• mental illness

Related Conditions & MeSH terms

• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Pulmonary Disease

Locations

Country	Name	City	State
China	Capital Medical University	Beijing
China	China-Japan Friendship Hospital	Beijing
China	Institue of Basic Medical Sciences Chinese Academy of Medical Sciences	Beijing
China	Peking University Third Hospital	Beijing
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine	Shanghai

Sponsors (6)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital	Capital Medical University, Chinese Academy of Medical Sciences, Peking University Third Hospital, Second Affiliated Hospital, School of Medicine, Zhejiang University, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	FEV1 annual decline in clinical practice	FEV1 measured by portable spirometry can reflect the progression of early COPD.	2021.1-2024.12
Secondary	dyspnea symptoms	Severity of dyspnea is positively correlated with COPD severity.	2021.1-2024.12
Secondary	frequency of COPD acute exacerbation	The frequency of COPD acute exacerbation refers to the number of acute exacerbations per year.	2021.1-2024.12
Secondary	chest imaging changes	Emphysema and obstruction in small airway will be evaluated by chest computed tomography(CT).	2021.1-2024.12
Secondary	systemic complications	Whether there are systemic complications is related to the prognosis of patients.	2021.1-2024.12