Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04583501
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps
  • Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Omalizumab — BIOLOGICAL
    Omalizumab will used as dose comparable to to 0.016 mg/kg/IU in serum.

Study Details

The goal of this study is to examine the mechanism of action of omalizumab in ex vivo tissue culture of whole human nasal polyps from patients with chronic rhino sinusitis with nasal polyposis (CRSwNP), such that specific molecular markers of inflammation can be identified.

Key Dates

Start date
Dec 15, 2020
Status verified
Aug 2024
Primary completion
Jul 12, 2024
Completion
Jul 12, 2024

Study Design

Enrollment
21 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Omalizumab
    Ex vivo exposure of excised human surgical polyp tissue to omalizumab.

Primary Outcome Measure

IgE tissue compartment distribution in nasal polyps as assessed by quantitative IgE expression [ Time Frame: 1 year ]

Locations (2)

FacilityCityStateZIPSite coordinators
Johns Hopkins Bayview Medical CenterBaltimoreMaryland21117-
Johns Hopkins HospitalBaltimoreMaryland21287-

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Johns Hopkins Bayview Medical Center· Baltimore, MDJohns Hopkins Hospital· Baltimore, MD

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