Role of IL-5R Signaling in Non-eosinophil Upper Airway Cells in CRSwNP

Recruiting

• Conditions: Aspirin-exacerbated Respiratory Disease; Nasal Polyps
• Interventions: Other: Non-Interventional

• Registration Number: NCT05672030
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

The overarching hypothesis of this proposal is that IL-5 acts on multiple sinus tissue cell types, including plasma cells and epithelial cells, to promote immune dysregulation, and that inhibition of IL-5 affects several relevant effector pathways that lead to clinical benefit.

Detailed Description

Further characterization of the role of IL-5Rα expression and function on human plasma cells will determine whether inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to plasma cell proliferation. Further characterization of human upper airway epithelial cell IL-5Rα expression and function will determine whether or not inhibiting IL-5 signaling on these cells offers therapeutic promise in other diseases related to epithelial dysfunction. IL-5Rα expression has been identified on several relevant sinus tissue effector cells, including on nasal polyp plasma cells and epithelial cells, and the aim of this study is to further the field by determining the consequences of IL-5 signaling on those cells.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-01
• Study First Submitted: 2023-01-03
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-05
• Last Update Submitted: 2023-01-05
• Last Update Posted: 2023-01-06
• Primary Completion: 2023-10-01
• Study Completion: 2023-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• AERD, CRSwNP, healthy controls

Exclusion Criteria

• Not on any systemic steroids or respiratory biologics at time of surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)	Non-Interventional	Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)
Aspirin-exacerbated respiratory disease (AERD)	Non-Interventional	Aspirin-exacerbated respiratory disease (AERD)
Healthy controls	Non-Interventional	Individuals who do not have AERD or CRSwNP

Primary Outcome Measures

Name	Time	Method
Nasal polyp plasma cell transcriptome	At baseline	Transcriptional profile of nasal polyp plasma cells in nasal polyps from patients with AERD and aspirin-tolerant CRSwNP

Secondary Outcome Measures

Name	Time	Method
IL-5Ra signaling on nasal epithelial cells	At baseline	Define the IL-5-elicited molecular features of upper airway nasal epithelial tissue from subjects with healthy sinus mucosa, CRSwNP, and AERD.
Function of IL-5Ra on nasal polyp plasma cells.	At baseline	Functional significance of IL-5Rα expression and IL-5 signaling on the plasma cells in nasal polyp tissue

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States