Heterogeneity and Development of Early COPD

NCT ID: NCT06096285

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

84 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Chronic Obstructive Pulmonary Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Young COPD

COPD patients with post-bronchodilator FEV1/FVC \< 0.70 diagnosed in the 20-50 year age range.

No interventions assigned to this group

Mild COPD

COPD patients with post-bronchodilator FEV1/FVC \< 0.70 and FEV1 ≥ 80% predicted.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

China-Japan Friendship Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jieping LEI, Ph.D.

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jieping Lei, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

China-Japan Friendship Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jieping Lei, Ph.D.

Role: CONTACT

+86 010 8420 6408

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Jieping Lei, Ph.D.

Role: primary

+86 010 8420 6408

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-ZF-9

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Disease-syndrome Characteristics of IPF
NCT07178392 NOT_YET_RECRUITING