The Role of IL5 in Epithelial Cell Integrity
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-100
SponsorJohns Hopkins University
About this trial
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
This trial does not accept healthy volunteersQualifiers
(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.
Disqualifiers
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
2. pregnant or lactating females,
3. prisoners,
Trial design
Design model
Parallel
Treatments tested in this trial
Mepolizumab
DrugIn vitro exposure of human nasal epithelial cells to mepolizumab
Treatment groups
8 Participants
are divided into 2 treatment groupsGroup A: Mepolizumab treatment armExperimental treatment 1 intervention
Group B: Control armNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Change in Type 1 inflammatory markers (ng/mL)
IL8 cytokine mRNA and protein expression
Time frame
0 to 48 hours2
Change in Type 2 inflammatory markers (ng/mL)
IL5 and thymic stromal lymphopoietin cytokine mRNA and protein expression
Time frame
0 to 48 hours3
Change in Innate immune inflammatory markers (ng/mL)
IL1 receptor mRNA and protein expression
Time frame
0 to 48 hours4
Change in epithelial barrier function protein expression (ng/mL)
E-cadherin
Time frame
0 to 48 hoursSponsors and contacts
Click on the lead sponsor to view all of their trials.
Johns Hopkins University
Lead sponsor
GlaxoSmithKline
Collaborator
Source ClinicalTrials.gov