Early COPD for China Pulmonary Health Study Stage II (EC-CPHS)

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

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

Study Overview

• Status: Recruiting
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 400

Contacts and Locations

• Study Contact: Name: Chen Wang; Phone Number: +86 010 69156477; Email: cyh-birm@263.net

Study Locations

• China
  • Beijing, China
    • Recruiting
    • Peking University Third Hospital
    • Contact: Yahong Chen
  • Beijing, China
    • Recruiting
    • China-Japan Friendship Hospital
    • Contact: Ting Yang
  • Beijing, China
    • Recruiting
    • Capital Medical University
  • Beijing, China
    • Recruiting
    • Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
    • Contact: Jing Wang
  • Shanghai, China
    • Recruiting
    • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
    • Contact: Weining Xiong
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • Second Affiliated Hospital of Zhejiang University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

early COPD patients and healthy controls

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
early COPD patients; younger than 50 years with 10 or more pack-years smoking history and any of these abnormalities: 1) early airflow limitation (post-bronchodilator forced expiratory volume in the first second(FEV1)/forced vital capacity(FVC) < lower limit of normal), 2) compatible CT abnormalities, 3) rapid decline in FEV1 (≥60 ml/yr).
Healthy people; healthy without any disabling, physical, neurological, or mental disease and were excluded living in a nursing home.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1 annual decline in clinical practice	FEV1 measured by portable spirometry can reflect the progression of early COPD.	2021.1-2024.12

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Collaborators: Cancer Institute and Hospital, 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; Capital Medical University
• Investigators: Principal Investigator: Yahong Chen, Peking University Third Hospital; Study Chair: Chen Wang, Institue of Basic Medical Sciences Chinese Academy of Medical Sciences; Principal Investigator: Ting Yang, China-Japan Friendship Hospital; Principal Investigator: Jing Wang, Institue of Basic Medical Sciences Chinese Academy of Medical Sciences; Principal Investigator: Huahao Shen, Second Affiliated Hospital of Zhejiang University School of Medicine; Principal Investigator: Wei Wang, Capital Medical University; Principal Investigator: Weining Xiong, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Anticipated): January 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: June 3, 2021
• First Submitted That Met QC Criteria: August 29, 2021
• First Posted (Actual): August 31, 2021

Study Record Updates

• Last Update Posted (Actual): August 31, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive
• Other Study ID Numbers: 82090011

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No