Examining the effects of mepolizumab on nasal epithelial cell health
The Role of IL5 in Epithelial Cell Integrity
This study is testing how the drug mepolizumab affects the health of nasal cells in people with chronic rhinosinusitis and nasal polyps to see if it helps reduce inflammation and improve cell function.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 8 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Drugs / interventions | omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, rituximab |
| Locations | 2 sites (Baltimore, Maryland and 1 other locations) |
| Trial ID | NCT05895929 on ClinicalTrials.gov |
What this trial studies
This laboratory study investigates how the drug mepolizumab affects the health and function of nasal epithelial cells in patients with chronic rhinosinusitis with nasal polyps. The study aims to understand how mepolizumab suppresses inflammation and maintains the integrity of epithelial cells. Researchers will conduct in vitro experiments using human primary nasal epithelial cells to assess inflammatory markers and barrier function. Additionally, high throughput RNA sequencing will be utilized to analyze gene expression changes in response to mepolizumab treatment.
Who should consider this trial
Good fit: Ideal candidates for this study are adults with chronic rhinosinusitis characterized by prolonged sinonasal inflammation and the presence of nasal polyps.
Not a fit: Patients under 18 years old, pregnant or lactating women, and those with certain confounding conditions will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatments for patients suffering from chronic rhinosinusitis with nasal polyps by enhancing epithelial cell function and reducing inflammation.
How similar studies have performed: Other studies have shown promising results with similar approaches targeting IL5 in chronic rhinosinusitis, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Baltimore, Maryland and 1 other locations
- Johns Hopkins Bayview Medical Center — Baltimore, Maryland, United States (Recruiting)
- Johns Hopkins Hospital — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Jean Kim, MD PhD — Johns Hopkins University
- Study coordinator: Jean Kim, MD PhD
- Email: jeankim@jhmi.edu
- Phone: 410-550-2644
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.