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

Chronic Obstructive Pulmonary Disease Clinical Trial

— EXHALBIO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437198
• Other study ID #: EXHALBIO
• Status: Recruiting
• Start date: March 26, 2024
• Est. completion date: March 2029

Study information

• Verified date: March 2024
• Source: Centre Hospitalier Intercommunal Creteil
• Contact: Jean-Claude PAIRON, PhD
• Phone: 01 45 02 20 93
• Email: jc.pairon[@]chicreteil.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: March 2029
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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)

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

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

Locations

Country	Name	City	State
France	Centre Hospitalier Intercommunal de Créteil	Créteil

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Intercommunal Creteil

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects	number and bacterial species	Baseline
Secondary	Number and dominant bacterial species in human exhalations according to smoking status	number and bacterial species	Baseline
Secondary	Number and dominant bacterial species in human exhalations according to age	number and bacterial species	Baseline
Secondary	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