Early COPD for China Pulmonary Health Study Stage II

Recruiting

• Conditions: Obstructive Pulmonary Disease

• Registration Number: NCT05028985
• Lead Sponsor: China-Japan Friendship Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-06-03
• Status Verified: 2021-08
• Study First Submitted QC: 2021-08-29
• Last Update Submitted: 2021-08-29
• Study First Posted: 2021-08-31
• Last Update Posted: 2021-08-31
• Primary Completion: 2025-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FEV1 annual decline in clinical practice	2021.1-2024.12	FEV1 measured by portable spirometry can reflect the progression of early COPD.

Secondary Outcome Measures

Name	Time	Method
dyspnea symptoms	2021.1-2024.12	Severity of dyspnea is positively correlated with COPD severity.
frequency of COPD acute exacerbation	2021.1-2024.12	The frequency of COPD acute exacerbation refers to the number of acute exacerbations per year.
chest imaging changes	2021.1-2024.12	Emphysema and obstruction in small airway will be evaluated by chest computed tomography(CT).
systemic complications	2021.1-2024.12	Whether there are systemic complications is related to the prognosis of patients.

Trial Locations

Locations (6)

Peking University Third Hospital; 🇨🇳 Beijing, China

Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine; 🇨🇳 Shanghai, China

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China

China-Japan Friendship Hospital; 🇨🇳 Beijing, China

Capital Medical University; 🇨🇳 Beijing, China

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences; 🇨🇳 Beijing, China