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

NCT ID: NCT05672030

Last Updated: 2025-11-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-12-01

Brief Summary

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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

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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.

Conditions

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Nasal Polyps Aspirin-exacerbated Respiratory Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Aspirin-exacerbated respiratory disease (AERD)

Aspirin-exacerbated respiratory disease (AERD)

Non-Interventional

Intervention Type OTHER

No intervention.

Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)

Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)

Non-Interventional

Intervention Type OTHER

No intervention.

Healthy controls

Individuals who do not have AERD or CRSwNP

Non-Interventional

Intervention Type OTHER

No intervention.

Interventions

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Non-Interventional

No intervention.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* AERD, CRSwNP, healthy controls

Exclusion Criteria

* Not on any systemic steroids or respiratory biologics at time of surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Tanya Laidlaw, MD

Associate Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tanya Laidlaw

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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2003P002088

Identifier Type: -

Identifier Source: org_study_id

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