Study of Microbiological Diversity in Exhaled Air in COPD and Free of COPD (EXHALBIO)

June 15, 2026 updated by: Centre Hospitalier Intercommunal Creteil

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
      • Créteil, France, 94010
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

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
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

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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number and dominant bacterial species in human exhalations of COPD subjects and non-COPD subjects
Time Frame: Baseline
number and bacterial species
Baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number and dominant bacterial species in human exhalations according to smoking status
Time Frame: Baseline
number and bacterial species
Baseline
Number and dominant bacterial species in human exhalations according to age
Time Frame: Baseline
number and bacterial species
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
number and bacterial species
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre Hospitalier Intercommunal Creteil

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jean Claude PAIRON, PhD, Chi Creteil

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 26, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 24, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 24, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EXHALBIO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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