NCT05028985

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 31, 2021

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2025

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

August 31, 2021

Status Verified

August 1, 2021

Enrollment Period

4 years

First QC Date

June 3, 2021

Last Update Submit

August 29, 2021

Conditions

Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

  • FEV1 annual decline in clinical practice

    FEV1 measured by portable spirometry can reflect the progression of early COPD.

    2021.1-2024.12

Secondary Outcomes (4)

  • dyspnea symptoms

    2021.1-2024.12

  • frequency of COPD acute exacerbation

    2021.1-2024.12

  • chest imaging changes

    2021.1-2024.12

  • systemic complications

    2021.1-2024.12

Study Arms (2)

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.

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

early COPD patients and healthy controls

You may qualify if:

  • younger than 50 years
  • smoking more than 10 pack-years
  • early airflow limitation(post-bronchodilator FEV1/FVC\< lower limit of normal)

You may not qualify if:

  • cancer
  • other respiratory diseases
  • mental illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

Capital Medical University

Beijing, China

RECRUITING

China-Japan Friendship Hospital

Beijing, China

RECRUITING

Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Shanghai Ninth People's Hospital, Shanghai JiaoTong university school of medicine

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

lung tissues, serum, bronchoalveolar lavage fluid, bronchial epithelial cells, sputum

MeSH Terms

Conditions

Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract Diseases

Study Officials

  • Chen Wang

    Institue of Basic Medical Sciences Chinese Academy of Medical Sciences

    STUDY CHAIR

  • 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

  • Yahong Chen

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

  • Weining Xiong

    Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chen Wang

CONTACT

+86 010 69156477cyh-birm@263.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Chair

Study Record Dates

First Submitted

June 3, 2021

First Posted

August 31, 2021

Study Start

January 1, 2021

Primary Completion

January 1, 2025

Study Completion

December 1, 2025

Last Updated

August 31, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(6)