Heterogeneity and Development of Early COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

Heterogeneity and Disease Development of Early Chronic Obstructive Pulmonary Disease

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06096285
• Other study ID #: 2023-ZF-9
• Status: Recruiting
• Start date: February 1, 2023
• Est. completion date: January 31, 2025

Study information

• Verified date: October 2023
• Source: China-Japan Friendship Hospital
• Contact: Jieping Lei, Ph.D.
• Phone: +86 010 8420 6408
• Email: jiepinglei[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 84
• Est. completion date: January 31, 2025
• Est. primary completion date: January 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Locations

Country	Name	City	State
China	China-Japan Friendship Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
China-Japan Friendship Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	FEV1		One year
Secondary	FVC		One year
Secondary	FEV1/FVC ratio		One year
Secondary	FEV1% predicted value		One year
Secondary	FVC% predicted value		One year
Secondary	The COPD Assessment Test scale	The COPD Assessment Test scores range from 0 to 40, with higher scores indicating worse symptoms.	One year
Secondary	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