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

Nasal Polyps Clinical Trial

— RECAP-5  

Official title:

Role of Interleukin 5 (IL-5) and IL-5R Signaling in Non-eosinophil Upper Airway Cells in Chronic Rhinosinusitis With Nasal Polyps

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05672030
• Other study ID #: 2003P002088
• Status: Recruiting
• Start date: October 1, 2022
• Est. completion date: December 1, 2023

Study information

• Verified date: January 2023
• Source: Brigham and Women's Hospital
• Contact: Tanya M Laidlaw
• Phone: 617-525-1034
• Email: tlaidlaw[@]bwh.harvard.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 1, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• AERD, CRSwNP, healthy controls

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Aspirin-exacerbated Respiratory Disease
• Nasal Polyps
• Polyps
• Respiration Disorders
• Respiratory Tract Diseases

Intervention

Other:
• Non-Interventional
No intervention.

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nasal polyp plasma cell transcriptome	Transcriptional profile of nasal polyp plasma cells in nasal polyps from patients with AERD and aspirin-tolerant CRSwNP	At baseline
Secondary	Function of IL-5Ra on nasal polyp plasma cells.	Functional significance of IL-5Ra expression and IL-5 signaling on the plasma cells in nasal polyp tissue	At baseline
Secondary	IL-5Ra signaling on nasal epithelial cells	Define the IL-5-elicited molecular features of upper airway nasal epithelial tissue from subjects with healthy sinus mucosa, CRSwNP, and AERD.	At baseline