Chronic Obstructive Pulmonary DiseaseEXHALBIONCT05437198
Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- collection of human exhalation
- How many people
- 240 participants
- Where
- 1 siteFrance
- Study dates
- 26 Mar 2024to Mar 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects with chronic obstructive pulmonary disease (COPD) and no-COPD control subjects
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Intercommunal de Créteil
Créteil, 94010
Jean-Claude Pairon, Pr, 157022093 ext. 0033, JC.Pairon@chicreteil.fr
About this study
Official title: Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD
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).
Read the 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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- collection of human exhalation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of human exhalationOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Other: collection of human exhalation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects
number and bacterial species
Measured: Baseline
Secondary outcomes (3)
Number and dominant bacterial species in human exhalations according to smoking status
number and bacterial species
Measured: Baseline
Number and dominant bacterial species in human exhalations according to age
number and bacterial species
Measured: Baseline
Number and dominant bacterial species in human exhalations for patients returning for consultation 1 year apart during the winter season
number and bacterial species
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start26 Mar 2024
- Primary completionMar 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Intercommunal Creteil
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean Claude PAIRON, PhD, Principal investigator, CHI créteil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437198
- Sponsor's protocol ID
- EXHALBIO
- Acronym
- EXHALBIO
- Status last verified
- Jun 2026
- First submitted
- 24 Jun 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Microbiological Diversity in Exhaled Air in Adult Subjects With Chronic Obstructive Pulmonary Disease (COPD) and Subjects Free of COPD
- ClinicalTrials.gov ID
- NCT05437198
- Acronym / sponsor ID
- EXHALBIO / EXHALBIO
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Centre Hospitalier Intercommunal CreteilUniversity, hospital or other
- Study start
- 26 Mar 2024 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | – | Other: collection of human exhalationPatients 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 |
| NO-Chronic Obstructive Pulmonary Disease | – | Other: collection of human exhalationThe 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with chronic obstructive pulmonary disease (COPD) and no-COPD control subjects
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of human exhalationthe 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 | Other | Chronic Obstructive Pulmonary Disease (COPD), NO-Chronic Obstructive Pulmonary Disease |
Primary outcome
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects
Time frame: Baseline
number and bacterial species
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jean Claude PAIRON, PhD principal investigator
CHI créteil
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Obstructive Pulmonary Disease, run by Centre Hospitalier Intercommunal Creteil at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Claude PAIRON, PhD (01 45 02 20 93, jc.pairon@chicreteil.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.