RECRUITING

The Role of IL5 in Epithelial Cell Integrity

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Conditions

Chronic Rhinosinusitis With Nasal PolypsChronic Rhinosinusitis (Diagnosis)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

The Role of IL5 in Epithelial Cell Integrity

Quick Facts

Study Start:2023-09-05
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05895929

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * (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. * (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. * (3) presence of nasal polyps seen on endoscopic exam or sinus CT scan.
  1. * 1. Children under the age of 18 will be excluded due to:
  2. 1. possible confounding diagnosis of cystic fibrosis and other non-Type 2 inflammatory etiologies that commonly presents with nasal polyps in the pediatric population.
  3. 2. lack of complete pneumatization of the majority of paranasal sinuses
  4. * 2. pregnant or lactating females,
  5. * 3. prisoners,
  6. * 4. mentally disabled
  7. * 5. persons unable to give informed consent will be contemplated for inclusion.
  8. * 6. disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm.
  9. * 7. exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery
  10. * 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.

Contacts and Locations

Study Contact

Jean Kim, MD PhD
CONTACT
410-550-2644
jeankim@jhmi.edu

Principal Investigator

Jean Kim, MD PhD
PRINCIPAL_INVESTIGATOR
Johns Hopkins University

Study Locations (Sites)

Johns Hopkins Bayview Medical Center
Baltimore, Maryland, 21117
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States

Collaborators and Investigators

Sponsor: Johns Hopkins University

  • Jean Kim, MD PhD, PRINCIPAL_INVESTIGATOR, Johns Hopkins University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-09-05
Study Completion Date2025-06

Study Record Updates

Study Start Date2023-09-05
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Rhinosinusitis With Nasal Polyps
  • Chronic Rhinosinusitis (Diagnosis)