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

NCT05672030 | Completed Results

• 1 other identifier: 2003P002088
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Nasal Polyps; Aspirin-exacerbated Respiratory Disease

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Nasal Polyp Plasma Cell Transcriptome

  We will determine the number of participants from whom a transcriptional profile of nasal polyp plasma cells is analyzable from bulk RNA sequencing of sorted nasal polyp plasma cells.

  At baseline

Secondary Outcomes (2)

• Number of Participants With Functional Readouts of IL-5Ra on Nasal Polyp Plasma Cells.

  At baseline

• Number of Patients for Whom IL-5Ra Signaling on Nasal Epithelial Cells Can be Analyzed

  At baseline

Study Arms (3)

Aspirin-exacerbated respiratory disease (AERD)

Aspirin-exacerbated respiratory disease (AERD)

Other: Non-Interventional

Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)

Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP)

Other: Non-Interventional

Healthy controls

Individuals who do not have AERD or CRSwNP

Other: Non-Interventional

Interventions

Non-Interventional OTHER

No intervention.

Aspirin-exacerbated respiratory disease (AERD); Aspirin-tolerant chronic rhinosinusitis with nasal polyps (CRSwNP); Healthy controls

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

AERD, CRSwNP, healthy controls undergoing planned elective sinus surgery.

You may qualify if:

• AERD, CRSwNP, healthy controls

You may not qualify if:

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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Nasal Polyps

Condition Hierarchy (Ancestors)

Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Tanya M. Laidlaw, MD, Associate Professor of Medicine
• Organization: Brigham and Women's Hospital, Allergy and Clinical Immunology

tlaidlaw@partners.org

6177329850

Study Officials

• Tanya Laidlaw

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine

Study Record Dates

• First Submitted: January 3, 2023
• First Posted: January 5, 2023
• Study Start: October 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 24, 2025
• Results First Posted: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)