EXHALBIO: Study of Microbiological Diversity in Exhaled Air in Adults With Chronic Obstructive Pulmonary Disease (COPD) and No-COPD ADULTS

Sponsor

Centre Hospitalier Intercommunal Creteil (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05437198

Collaborator

(none)

240

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	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 Design

Study Type:

Observational

Anticipated Enrollment :

240 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

Study of Microbiological Diversity in the Exhaled Air in COPD and Non-COPD Adult Subjects

Anticipated Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2026

Anticipated Study Completion Date :

Mar 1, 2028

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects [Baseline]
number and bacterial species

Secondary Outcome Measures

Number and dominant bacterial species in human exhalations according to smoking status [Baseline]
number and bacterial species
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

For COPD:

Patients with chronic obstructive pulmonary disease Age: over 18

For no-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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Centre Hospitalier Intercommunal Creteil

Investigators

Principal Investigator: Jean Claude PAIRON, PhD, CHI créteil

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Intercommunal Creteil

ClinicalTrials.gov Identifier:

NCT05437198

Other Study ID Numbers:

EXHALBIO

First Posted:

Jun 29, 2022

Last Update Posted:

Jun 29, 2022

Last Verified:

Jun 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Lung Diseases

Lung Diseases, Obstructive

Pulmonary Disease, Chronic Obstructive

Study Results

No Results Posted as of Jun 29, 2022