Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD (EXHALBIO)

Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD

COPD and non-COPD patients will be included in the study after collection of their non-objection. The exhalation will be collected to study the microbiological diversity of human exhalations.

a second collection for the year +1 will be made, at the same time (between October and March).

Study Overview

• Status: Recruiting
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Other: collection of human exhalation

Detailed Description

The subjects will be recruited during a medical visit in the Departments of Pneumology and Occupational and Environmental Pathologies.

After information and inclusion of the subject in the study, a collection of clinical data, the state of health and the smoking status of the subject will be carried out by the clinical study technician.

A collection of the exhalation will also be carried out by the clinical study technician.

Several groups of subjects will be formed according to pathologies (COPD versus non-COPD), age and smoking status

• Study Type: Observational
• Enrollment (Estimated): 240

Contacts and Locations

• Study Contact: Name: Jean-Claude PAIRON, PhD; Phone Number: 01 45 02 20 93; Email: jc.pairon@chicreteil.fr
• Study Contact Backup: Name: Camille JUNG, PhD; Phone Number: 0145175000; Email: camille.jung@chicreteil.fr

Study Locations

• France
  • Créteil, France, 94010
    • Recruiting
    • Centre Hospitalier Intercommunal de Creteil
    • Contact: Jean-Claude Pairon, Pr; Phone Number: 0033 157022093; Email: JC.Pairon@chicreteil.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with chronic obstructive pulmonary disease (COPD) and no-COPD control subjects

Description

Inclusion Criteria:

For COPD:

• Patients with chronic obstructive pulmonary disease
• Age: over 18

For non-COPD

• Absence of chronic obstructive pulmonary disease
• Age: between 18 and 30 years old and between 45 and 70 years old

Exclusion Criteria:

• Taking certain medications in the month preceding the sample (antibiotics, systemic corticosteroids, immunosuppressants)
• Person under guardianship or curatorship
• Pregnant or breastfeeding women
• Person unable to express his/her opposition, person deprived of liberty
• Existence of a chronic infectious pulmonary pathology such as (dilation of the bronchi, cystic fibrosis)

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Chronic Obstructive Pulmonary Disease (COPD); Patients with chronic obstructive pulmonary disease will be recruited from the pulmonology or occupational pathology department. They are either active smokers or ex-smokers. They are over 18 years old	Other: collection of human exhalation; the collection of the exhalation will be carried out with a non-invasive device manufactured by a Chinese company. The collection of exhalation consists of the subject inhaling through the nose and exhaling gently through the mouth through a plastic straw for a time set at 5 min in the device
NO-Chronic Obstructive Pulmonary Disease; The no-COPD are controls followed in chi créteil for another pathology. They are between 18 and 30 years old and 45 and 70 years old. They are either: Ex-smoker; Active smoker; Non-smoker	Other: collection of human exhalation; the collection of the exhalation will be carried out with a non-invasive device manufactured by a Chinese company. The collection of exhalation consists of the subject inhaling through the nose and exhaling gently through the mouth through a plastic straw for a time set at 5 min in the device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects	number and bacterial species	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number and dominant bacterial species in human exhalations according to smoking status	number and bacterial species	Baseline
Number and dominant bacterial species in human exhalations according to age	number and bacterial species	Baseline
Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season	number and bacterial species	1 year

Collaborators and Investigators

• Sponsor: Centre Hospitalier Intercommunal Creteil
• Investigators: Principal Investigator: Jean Claude PAIRON, PhD, Chi Creteil

Study record dates

Study Major Dates

• Study Start (Actual): March 26, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: June 24, 2022
• First Posted (Actual): June 29, 2022

Study Record Updates

• Last Update Posted (Actual): June 12, 2025
• Last Update Submitted That Met QC Criteria: June 11, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
• Other Study ID Numbers: EXHALBIO

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