A Study About Association Between Microbiome, Metabolome and Clinical Characteristics in COPD Patients

Asan Medical Center

Status: Not yet enrolling

Conditions: Chronic Obstructive Pulmonary Disease

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06101459

2023-1049

Details and patient eligibility

About

The goal of this observational registry study is to compare characteristics of gut and sputum microbiome and metabolome among COPD patients with significant smoking history, COPD patients without significant smoking history and healthy smoker. Additionally, the investigators investigate the difference of blood metabolites and peripheral blood mononuclear cells level among groups.

The main questions it aims to answer are:

• Are there significant difference in fecal or sputum microbiome and metabolome between COPD patients and healthy smoker?
• Are there any distinct characteristics in microbiome and metabolome in COPD with COPD patients with significant smoking history, COPD patients without significant smoking history compared with healthy smoker?
• Are there any difference in blood metabolites and peripheral blood mononuclear cells levels among patients with significant smoking history, COPD patients without significant smoking history and healthy smoker
• Might distinct characteristics of microbiome and metabolites in COPD patients be related to worse clinical outcomes in COPD patients?

Enrollment: 300 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• COPD Patients, defined by FEV1/FVC <0.7, who

  • agree with informed consent
  • have no history of acute exacerbation within 3 months

• Healthy smoker without airflow limitation, defined by FEV1/FVC ≥0.7, who

  • have smoking history with at least 30 pack-year
  • agree with informed consent
  • do not use medication for chronic respiratory disease

Exclusion criteria

• Withdrawal of informed consent
• History of acute exacerbation or antibiotics use within 3 months
• Difficulty to collect adequate stool, sputum and blood samples

Trial design

300 participants in 3 patient groups

COPD patient with significant smoking history

Description:

Patients with following conditions 1. smoking history more than 30 pack\*year 2. FEV1/FVC ratio \<0.7 3. No acute exacerbation history within 3 months

COPD patient without significant smoking history

Description:

Patients with following conditions 1. smoking history less than 0.5 pack\*year 2. FEV1/FVC ratio \<0.7 3. No acute exacerbation history within 3 months

Healthy smoker

Description:

Patients with following conditions 1. smoking history more than 30 pack\*year 2. FEV1/FVC ratio ≥0.7 3. No current use of medication for any chronic respiratory disease