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Clinical Trials/NCT05437198
NCT05437198RecruitingNot Applicable

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

Centre Hospitalier Intercommunal Creteil2 sites in 1 country240 target enrollmentStarted: March 26, 2024Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
240
Locations
2
Primary Endpoint
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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)

Arms & Interventions

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

Intervention: collection of human exhalation (Other)

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

Intervention: collection of human exhalation (Other)

Outcomes

Primary Outcomes

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

Time Frame: Baseline

number and bacterial species

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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