Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: NCT05437198
• Lead Sponsor: Centre Hospitalier Intercommunal Creteil

Brief Summary

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).

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 Timeline

• Study First Submitted: 2022-06-24
• Study First Submitted QC: 2022-06-24
• Study First Posted: 2022-06-29
• Study Start: 2024-03-26
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-11
• Last Update Posted: 2025-06-12
• Primary Completion: 2028-03
• Study Completion: 2029-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects	Baseline	number and bacterial species

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Intercommunal de Créteil; 🇫🇷 Créteil, France