The Role of IL5 in Epithelial Cell Integrity

Last updated: February 4, 2025
Sponsor: Johns Hopkins University
Overall Status: Active - Recruiting

Phase

1

Condition

Sinusitis

Nasal Obstruction

Soft Tissue Infections

Treatment

Mepolizumab

Clinical Study ID

NCT05895929
IRB00363909
  • Ages 18-100
  • All Genders

Study Summary

The goal of this laboratory study is the examine the effect of mepolizumab drug on the health and function of the cells lining the human nasal airways in vitro cell culture derived from patients with chronic rhinosinusitis with nasal polyposis. The main questions the study aims to study are:

  1. To see what mepolizumab does to suppress inflammation of the human cells.

  2. To see what mepolizumab does to maintain barrier integrity of epithelial cells

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • (1) sinonasal inflammation for greater than 12 weeks which include at least 2 of thefollowing symptoms: nasal obstruction/congestion, nasal discharge (anterior orposterior), facial pressure/pain, reduction of sense of smell.

  • (2) confirmation of the clinical symptoms by: (2a) CT scan evidence of paranasalsinus mucosal inflammation, and/or (2b) endoscopic exam evidence of purulence fromthe sinuses or ostiomeatal complex; and

  • (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.

Exclusion

Exclusion Criteria:

  1. Children under the age of 18 will be excluded due to:

  2. possible confounding diagnosis of cystic fibrosis and other non-Type 2inflammatory etiologies that commonly presents with nasal polyps in thepediatric population.

  3. lack of complete pneumatization of the majority of paranasal sinuses

  1. pregnant or lactating females,
  1. prisoners,
  1. mentally disabled
  1. persons unable to give informed consent will be contemplated for inclusion.
  1. disease secondary to a clearly defined anatomic process, such as facial trauma,and obstruction due to sinonasal neoplasm.
  1. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery
  1. exposure to immunomodulatory biologics will be excluded. These include, but arenot limited to systemic treatment with biologics omalizumab, dupilumab,mepolizumab, benralizumab, reslizumab, or rituximab.

Study Design

Total Participants: 8
Treatment Group(s): 1
Primary Treatment: Mepolizumab
Phase: 1
Study Start date:
September 05, 2023
Estimated Completion Date:
June 30, 2026

Study Description

The investigators hypothesize that anti-IL5 treatment will promote epithelial cell function by inhibition of Type 1 and innate immune mediated inflammation and epithelial-mesenchymal transition resulting from IL5 induction.

Aim 1. To test the hypothesis that anti-IL5 therapy results in inhibition of epithelial cell dysfunction including epithelial derived inflammatory responses and barrier dysfunction, the investigators will examine the effect of in vitro anti-IL5 mepolizumab exposure of human primary nasal epithelial cells from chronic rhinosinusitis with nasal polyposis on Type 1, Type 2 and innate immune inflammatory markers, and markers of epithelial cell barrier function.

Aim 2. To examine the effect of mepolizumab to broadly modulate the expression of Type 2, Type 1, Type 3, and innate immune inflammatory gene responses in human nasal airway epithelial cells, the investigators will perform high throughput RNA sequencing on IL5 primed differentiated human primary nasal epithelial cells exposed to the presence and absence of mepolizumab in vitro cell culture which are derived from patients with chronic rhinosinusitis with nasal polyposis. These studies will provide an unbiased approach to identification of biomarkers resulting from anti-IL5 treatment.

Connect with a study center

  • Johns Hopkins Bayview Medical Center

    Baltimore, Maryland 21117
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

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