Clinical trial NCT05028985: Early COPD for China Pulmonary Health Study Stage II
Official title: A Cohort Study of Early Chronic Obstructive Pulmonary Disease for China Pulmonary Health Study Stage II
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
Collaborators: name: Chinese Academy of Medical Sciences
name: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Capital Medical University
name: Peking University Third Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
First posted: 2021-08-31
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: early COPD patients and healthy controls

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.

Eligibility criteria: 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

Primary outcomes:
measure: FEV1 annual decline in clinical practice
timeFrame: 2021.1-2024.12
Secondary outcomes:
measure: dyspnea symptoms
timeFrame: 2021.1-2024.12
measure: frequency of COPD acute exacerbation
timeFrame: 2021.1-2024.12
measure: chest imaging changes
timeFrame: 2021.1-2024.12
measure: systemic complications
timeFrame: 2021.1-2024.12
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital of Zhejiang University School of Medicine
state: Zhejiang
city: Beijing
country: China
facility: Capital Medical University
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
city: Beijing
country: China
facility: Peking University Third Hospital
city: Shanghai
country: China
facility: Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine
Study officials:
affiliation: Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
name: Chen Wang
role: STUDY_CHAIR
affiliation: China-Japan Friendship Hospital
name: Ting Yang
role: PRINCIPAL_INVESTIGATOR
affiliation: Institue of Basic Medical Sciences Chinese Academy of Medical Sciences
name: Jing Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Second Affiliated Hospital of Zhejiang University School of Medicine
name: Huahao Shen
role: PRINCIPAL_INVESTIGATOR
affiliation: Capital Medical University
name: Wei Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking University Third Hospital
name: Yahong Chen
role: PRINCIPAL_INVESTIGATOR
affiliation: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Weining Xiong
role: PRINCIPAL_INVESTIGATOR
References: