CompletedEarly Phase 1

The Role of IL5 in Epithelial Cell Integrity

United States17 participantsStarted 2023-09-05

Plain-language 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

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.
. lack of complete pneumatization of the majority of paranasal sinuses

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Type 1 inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in Type 2 inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in Innate immune inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in epithelial barrier function protein expression (ng/mL)

Timeframe: 0 to 48 hours

Change in epithelial integrity markers (staining intensity units)

Timeframe: 0 to 48 hours

Trial details

NCT IDNCT05895929

SponsorJohns Hopkins University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-31

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps trials

Plain-language summary

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.
. lack of complete pneumatization of the majority of paranasal sinuses

What they're measuring

Change in Type 1 inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in Type 2 inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in Innate immune inflammatory markers (ng/mL)

Timeframe: 0 to 48 hours

Change in epithelial barrier function protein expression (ng/mL)

Timeframe: 0 to 48 hours

Change in epithelial integrity markers (staining intensity units)

Timeframe: 0 to 48 hours