NCT06676397

Brief 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. The study aims to advance understanding of eosinophil diversity, which could guide new therapeutic approaches .

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Dec 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress66%
Dec 2024Feb 2027

First Submitted

Initial submission to the registry

October 11, 2024

Completed
26 days until next milestone

First Posted

Study publicly available on registry

November 6, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

December 4, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 4, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2027

Last Updated

November 6, 2024

Status Verified

October 1, 2024

Enrollment Period

2 years

First QC Date

October 11, 2024

Last Update Submit

November 4, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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)

    at inclusion

Study Arms (5)

Severe Asthma Patients : Biologic Naïves

OTHER

Severe Asthma Patients : Biologic Naïves

Procedure: Blood Punction

Severe Asthma Patients: Responders to Biologics

OTHER

Severe Asthma Patients: Responders to Biologics

Procedure: Blood Punction

Severe Asthma Patients: Non Responders to Biologics

OTHER

Severe Asthma Patients: Non Responders to Biologics

Procedure: Blood Punction

Mild asthmatics

OTHER

Mild asthmatics

Procedure: Blood Punction

Healthy Controls

OTHER

Healthy Controls

Procedure: Blood Punction

Interventions

venous blood sampling

Healthy ControlsMild asthmaticsSevere Asthma Patients : Biologic NaïvesSevere Asthma Patients: Non Responders to BiologicsSevere Asthma Patients: Responders to Biologics

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Non-eosinophilic asthma
  • Coexistence of a chronic eosinophilic inflammatory condition other than asthma
  • Other respiratory conditions (cystic fibrosis, COPD, allergic bronchopulmonary aspergillosis, etc.)
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pulmonary Eosinophilia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHypereosinophilic SyndromeEosinophiliaLeukocyte DisordersHematologic DiseasesHemic and Lymphatic Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2024

First Posted

November 6, 2024

Study Start

December 4, 2024

Primary Completion (Estimated)

December 4, 2026

Study Completion (Estimated)

February 4, 2027

Last Updated

November 6, 2024

Record last verified: 2024-10