Asthma; EosinophilicHOMEOSNCT06676397
Homeostatic Roles of Eosinophils in Asthma
A study testing Blood Punction in people with Asthma; Eosinophilic, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma; Eosinophilic
- What is being tested?
- Blood Punction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2024to 4 Feb 2027
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients diagnosed with mild asthma with severe asthma (Biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma
- Signature of informed consent
- Affiliation with the French social security system
Who cannot join
- Non-eosinophilic asthma
- Coexistence of a chronic eosinophilic inflammatory condition other than asthma
- Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)
- Treatment with corticosteroids within 10 days prior to inclusion
- Active smoking or a smoking history of more than 20 pack-years
- Pregnant women
Show all 10Show fewer
- Legal incapacity or limited legal capacity
- Subject unlikely to cooperate with the study and/or with anticipated low cooperation as assessed by the investigator
- Subject without health insurance
- Subject currently in an exclusion period of another study or as indicated by the "national registry of volunteers."
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Characterization of the Homeostatic Functions of Eosinophils in Asthma: An Exploratory Study
The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .
- Conditions
- Asthma; Eosinophilic
- Being tested
- Blood Punction
- Medical subject headings
- Pulmonary Eosinophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood PunctionProcedure or surgery
venous blood sampling
| Study group | Role | What they receive |
|---|---|---|
| Severe Asthma Patients : Biologic Naïves | Other | Severe Asthma Patients : Biologic Naïves Receives: Procedure: Blood Punction |
| Severe Asthma Patients: Responders to Biologics | Other | Severe Asthma Patients: Responders to Biologics Receives: Procedure: Blood Punction |
| Severe Asthma Patients: Non Responders to Biologics | Other | Severe Asthma Patients: Non Responders to Biologics Receives: Procedure: Blood Punction |
| Mild asthmatics | Other | Mild asthmatics Receives: Procedure: Blood Punction |
| Healthy Controls | Other | Healthy Controls Receives: Procedure: Blood Punction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow cytometry based eosinophil phenotyping : Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity)
Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity)
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2024
- Study start4 Dec 2024 (estimated)
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma; EosinophilicStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06676397
- Sponsor's protocol ID
- 2024/877
- Acronym
- HOMEOS
- Status last verified
- Oct 2024
- First submitted
- 11 Oct 2024
- Last updated
- 6 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of the Homeostatic Functions of Eosinophils in Asthma: An Exploratory Study
- ClinicalTrials.gov ID
- NCT06676397
- Acronym / sponsor ID
- HOMEOS / 2024/877
- Conditions
- Asthma; Eosinophilic
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- 4 Dec 2024 (estimated)
- Primary completion
- 4 Dec 2026 (estimated)
- Study completion
- 4 Feb 2027 (estimated)
- First posted
- 6 Nov 2024 (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.
The HOMEOS study is an exploratory, observational, and monocentric research. It focuses on characterizing the homeostatic roles of eosinophils in severe asthma. The primary objective is to identify eosinophil subpopulations among different groups of severe asthmatic patients using flow cytometry. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Severe Asthma Patients : Biologic Naïves | Other | Procedure: Blood PunctionSevere Asthma Patients : Biologic Naïves |
| Severe Asthma Patients: Responders to Biologics | Other | Procedure: Blood PunctionSevere Asthma Patients: Responders to Biologics |
| Severe Asthma Patients: Non Responders to Biologics | Other | Procedure: Blood PunctionSevere Asthma Patients: Non Responders to Biologics |
| Mild asthmatics | Other | Procedure: Blood PunctionMild asthmatics |
| Healthy Controls | Other | Procedure: Blood PunctionHealthy Controls |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients diagnosed with mild asthma with severe asthma (Biologic-naïve, responders to anti-eosinophil biologic therapies and resistant to anti-eosinophil biologic therapies), control subjects without asthma
- Signature of informed consent
- Affiliation with the French social security system
Key exclusion criteria (10 listed)
- Non-eosinophilic asthma
- Coexistence of a chronic eosinophilic inflammatory condition other than asthma
- Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)
- Treatment with corticosteroids within 10 days prior to inclusion
- Active smoking or a smoking history of more than 20 pack-years
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 |
|---|---|---|
| Blood Punctionvenous blood sampling | Procedure or surgery | Healthy Controls, Mild asthmatics, Severe Asthma Patients : Biologic Naïves, Severe Asthma Patients: Non Responders to Biologics, Severe Asthma Patients: Responders to Biologics |
Primary outcome
Flow cytometry based eosinophil phenotyping : Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity)
Time frame: at inclusion
Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity)
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 6 Nov 2024.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Blood Punction in people with Asthma; Eosinophilic, run by Centre Hospitalier Universitaire de Besancon.
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 3 inclusion and 10 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: opening soon, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Cindy Barnig, MD, PhD (+33 3 81 66 82 04, cindy.barnigbarnig@univ-fcomte.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow cytometry based eosinophil phenotyping : Expression levels of cell markers CD62L, CD123, CD101, CD11b, CD193, CD125, Siglec-8 on blood eosinophils quantified by flow cytometry and expressed in % and MFI (mean fluorescence intensity) (time frame: at inclusion). 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 6 Nov 2024.