Heterogeneity and Development of Early COPD

NCT06096285 | Unknown DMC

• 1 other identifier: 2023-ZF-9
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; Early COPD; Heterogeneity; Disease development

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• FEV1

  One year

• FVC

  One year

• FEV1/FVC ratio

  One year

• FEV1% predicted value

  One year

• FVC% predicted value

  One year

Study Arms (7)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China-Japan Friendship Hospital: lead

Study Sites (1)

China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood sample

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jieping Lei, Ph.D.

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jieping Lei, Ph.D.

CONTACT

+86 010 8420 6408; jiepinglei@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2023
• First Posted: October 23, 2023
• Study Start: February 1, 2023
• Primary Completion: January 31, 2025
• Study Completion: January 31, 2025
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)