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Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis — CRSwNP  

Nasal Polyps Clinical Trial

Official title:
Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Clinical Trial Summary

The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.

Clinical Trial Description

Objectives: Aim 1. The investigation will identify the specific tissue compartment distribution of immunoglobulin E (IgE) expression within human nasal polyps. Colocalization studies will examine functional interaction of IgE with effector cells. Aim 2. The investigation will examine the direct effect of omalizumab on expression of Type 2, 1, and 3 inflammatory pathways in human nasal polyp tissue from phenotypically characterized chronic rhinosinusitis with nasal polyposis (CRSwNP) patients. Study Rationale: Human nasal polyps express high local tissue IgE. However, the tissue distribution, cellular location and functional consequence of IgE accumulation within the polyp tissue is not known. Phase 3 studies of omalizumab demonstrated efficacy, with responders. However, the reason for non-responder outcomes in a subset of CRSwNP patients was not understood. Therefore, the goal of this study is to examine the mechanism of action of omalizumab in CRSwNP, such that specific responders for this treatment can be identified and therapy can be optimally directed. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04583501
Study type Interventional
Source Johns Hopkins University
Contact Jean Kim, MD PhD
Phone 410-550-0460
Email jeankim@jhmi.edu
Status Recruiting
Phase Early Phase 1
Start date December 15, 2020
Completion date May 30, 2024
View Details
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