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

NCT05437198 | Recruiting

• 1 other identifier: EXHALBIO
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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).

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects

  number and bacterial species

  Baseline

Secondary Outcomes (3)

• Number and dominant bacterial species in human exhalations according to smoking status

  Baseline

• Number and dominant bacterial species in human exhalations according to age

  Baseline

• Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season

  1 year

Study Arms (2)

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

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

Interventions

collection of human exhalation OTHER

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

Chronic Obstructive Pulmonary Disease (COPD); NO-Chronic Obstructive Pulmonary Disease

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Hospitalier Intercommunal Creteil: lead

Study Sites (1)

Centre Hospitalier Intercommunal de Créteil

Créteil, 94010, France

RECRUITING

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Claude PAIRON, PhD

  CHI créteil

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Claude PAIRON, PhD

CONTACT

01 45 02 20 93; jc.pairon@chicreteil.fr

Camille JUNG, PhD

CONTACT

0145175000; camille.jung@chicreteil.fr

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2022
• First Posted: June 29, 2022
• Study Start: March 26, 2024
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2029
• Last Updated: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)