Homeostatic Roles of Eosinophils in Asthma (HOMEOS)

November 4, 2024 updated by: Centre Hospitalier Universitaire de Besancon

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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."

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

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Severe Asthma Patients : Biologic Naïves
Procedure: Blood Punction
venous blood sampling
Other: Severe Asthma Patients: Responders to Biologics
Procedure: Blood Punction
venous blood sampling
Other: Severe Asthma Patients: Non Responders to Biologics
Procedure: Blood Punction
venous blood sampling
Other: Mild asthmatics
Procedure: Blood Punction
venous blood sampling
Other: Healthy Controls
Procedure: Blood Punction
venous blood sampling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
at inclusion

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Besancon

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 (Estimated)

December 4, 2024

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

February 4, 2027

Study Registration Dates

First Submitted

October 11, 2024

First Submitted That Met QC Criteria

November 4, 2024

First Posted (Actual)

November 6, 2024

Study Record Updates

Last Update Posted (Actual)

November 6, 2024

Last Update Submitted That Met QC Criteria

November 4, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/877

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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