Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2026-01-02 @ 2:22 PM
Study NCT ID:
NCT04384835
Status:
COMPLETED
Last Update Posted:
2023-06-01
First Post:
2020-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients
Sponsor:
University Hospital, Toulouse
Organization:
Study Overview
Official Title:
Analysis of Sexual Bias in Type 2 Innate Lymphoid Cells (ILC2) in Asthmatic Patients: Role of Androgens
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
IL-C2
Brief Summary:
Asthma is more common in females than in males but the difference has not been explained yet. Group 2 innate lymphoid cells (ILC2) have recently emerged as critical players in the initiation of allergic responses but their implications in the difference between males and females in terms of asthma prevalence has not been fully studied. The aim of this project is to compare the proportion of ILC2 in blood between males and females with asthma.
Detailed Description:
Asthma is more common in males until puberty but becomes more prevalent and more severe in females after puberty suggesting a protective action of male sex hormones. ILC2 have recently emerged as critical players in the initiation of allergic responses. The present team established that androgens, signaling through the nuclear receptor 3 C4 (NR3C4) androgen receptor (AR), negatively control ILC2 at steady state and during lung inflammation. Relevant to this application, females with asthma have more circulating ILC2 than males. The present hypothesis is that harnessing AR signaling in ILC2 may provide a new therapeutic approach to down regulate tissue resident ILC2. This project will analyze the sex bias in circulating ILC2 in female and male patients with moderate to severe asthma. In females with asthma, the team will purify circulating ILC2 from peripheral blood mononuclear cells (PBMC) and expand them in vitro using cytokines and stromal cells in the presence of AR antagonist or agonist ligands. Bulk ILC2 cultures at day 7 will used to measure the expression profile of various gene, including AR.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: