Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: collection of human exhalation.
- Who it may be relevant to
- Registry conditions: Chronic Obstructive Pulmonary Disease. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD
Overview
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
Interventions
- 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
Primary outcome measures
- Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects [Time frame: Baseline]
Secondary outcome measures (3)
- Number and dominant bacterial species in human exhalations according to smoking status [Time frame: Baseline]
- Number and dominant bacterial species in human exhalations according to age [Time frame: Baseline]
- Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season [Time frame: 1 year]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-control
Study locations
France · 1 center
- Centre Hospitalier Intercommunal de Créteil — Créteil
Identifiers
NCT: NCT05437198 · EXHALBIO