The Role of IL5 in Epithelial Cell Integrity

• Status: Not yet recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborator: GlaxoSmithKline

Criteria

Inclusion Criteria:

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

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

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

Exclusion Criteria:

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

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

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

• 2. pregnant or lactating females,

• 3. prisoners,

• 4. mentally disabled

• 5. persons unable to give informed consent will be contemplated for inclusion.

• 6. disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.

• 7. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery

• 8. exposure to immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab.