Heterogeneity and Development of Early COPD

Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease

This study aims to investigate the clinical characteristics and heterogeneities of early chronic obstructive pulmonary disease (COPD), to determine the disease development of early COPD, and to establish a multidimensional model for predicting the outcomes of early COPD.

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease

• Study Type: Observational
• Enrollment (Estimated): 84

Contacts and Locations

• Study Contact: Name: Jieping Lei, Ph.D.; Phone Number: +86 010 8420 6408; Email: jiepinglei@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100029
      • Recruiting
      • China-Japan Friendship Hospital
      • Contact: Jieping Lei, Ph.D.; Phone Number: +86 010 8420 6408; Email: jiepinglei@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

This study plans to involve the individuals with different early COPD status, as well as comparable controls.

Description

Inclusion Criteria:

• The individuals who meet the defining criteria of PRISm, COPD Stage 0, Pre-COPD, Early COPD, Young COPD, and Mild COPD, according to the latest GOLD documents and publications.

Exclusion Criteria:

• Age < 18 years or > 80 years;
• Pregnant or maternal women;
• Having malignant and active tumor(s), and receiving treatment;
• Undergoing a surgical operation;
• Having problems with mental awareness;
• Having difficulties in daily activities;
• Participating in other interventional clinical trials.

Study Plan

How is the study designed?

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort
Preserved ratio impaired spirometry (PRISm); People with post-bronchodilator forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 0.70 and FEV1 and/or FVC < 80% predicted, or FEV1/FVC ≥ lower limit of normal (LLN) and FEV1 < LLN.
COPD Stage 0; People who had COPD-related risk factor exposure (e.g. cigarette smoke) and/or presented with respiratory symptoms (e.g. chronic cough, and/or sputum production) whereas with normal pulmonary function.
Pre-COPD; People (importantly, of any age) who had respiratory symptoms (e.g. cough, sputum production, dyspnea, and/or exacerbation) with or without detectable structural (e.g. thoracic computed tomography (CT) emphysema, small and/or large airway impairments) and/or functional (e.g. low diffusion capacity for carbon monoxide (DLCO), hyperinflation, small airway obstruction, and/or accelerated FEV1 decline) abnormalities, in the absence of airflow limitation, and who might (or not) develop persistent airflow limitation (i.e. COPD) over time.
Early COPD; People who were younger than 50 years with ten or more pack-years smoking history and any of these abnormalities: i) early airflow limitation (post-bronchodilator FEV1/FVC < LLN), ii) compatible thoracic CT abnormalities, iii) rapid decline in FEV1 (> 60 ml/year) that was accelerated relative to FVC.
Young COPD; COPD patients with post-bronchodilator FEV1/FVC < 0.70 diagnosed in the 20-50 year age range.
Mild COPD; COPD patients with post-bronchodilator FEV1/FVC < 0.70 and FEV1 ≥ 80% predicted.
Controls; People who were not belonged to any of above six early COPD status, and with pre- and post-bronchodilator FEV1/FVC ≥ 0·70, and with post-bronchodilator FEV1/FVC ≥ LLN.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with COPD exacerbation	COPD exacerbation refers to acute deterioration of respiratory symptoms (e.g. cough, sputum, wheeze, dyspnea), especially resulting in hospital visit or admission.	One year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
FEV1		One year
FVC		One year
FEV1/FVC ratio		One year
FEV1% predicted value		One year
FVC% predicted value		One year
The COPD Assessment Test scale	The COPD Assessment Test scores range from 0 to 40, with higher scores indicating worse symptoms.	One year
The modified Medical Research Council dyspnea scale	The modified Medical Research Council dyspnea scores range from 0 to 4, with higher scores indicating more severe dyspnea.	One year

Collaborators and Investigators

• Sponsor: China-Japan Friendship Hospital
• Investigators: Principal Investigator: Jieping Lei, Ph.D., China-Japan Friendship Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: October 15, 2023
• First Submitted That Met QC Criteria: October 19, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Heterogeneity; Chronic obstructive pulmonary disease; Early COPD; Disease development
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Chronic Disease; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: 2023-ZF-9

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