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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05672030
Other study ID # 2003P002088
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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