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CompletedEarly phase 1

Preclinical Studies of Omalizumab in Chronic Rhinosinusitis With Nasal Polyposis

Key facts

Who runs it
Johns Hopkins University
Where
Baltimore, United StatesSee the 2 sites
Trial code
Status
Completed
Phase
Early phase 1
People taking part
21 people enrolled
Started
15 Dec 2020
Ended
12 Jul 2024
Type of study
Interventional
Treatments tested
  • Omalizumab
Record updated
13 August 2024

Who can take part

Age
18 years to 100 years
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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
  • 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
  • Presence of nasal polyps seen on endoscopic exam or sinus CT scan
  • Adults from age of 18-100 will be eligible
  • All potential participants will be required to sign an Institutional Review Board (IRB) approved research consent form

Who cannot take part

  • To eliminate confounding variables in our ex vivo experimental studies, any subject with a history of exposure to oral or systemic IV glucocorticoids within 2 weeks of surgery or any immunomodulatory biologics will be excluded. These include, but are not limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab, benralizumab, reslizumab, or rituximab
  • The subject groups will also exclude those with disease secondary to a clearly defined anatomic process, such as facial trauma, and obstruction due to sinonasal neoplasm
  • Children under the age of 18 will be excluded
  • No pregnant or lactating females, prisoners, mentally disabled, or persons unable to give informed consent will be contemplated for inclusion

Where in United States

  • Johns Hopkins Bayview Medical CenterBaltimore, United States
  • Johns Hopkins HospitalBaltimore, United States

About the trial

What the trial wants to find out

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.

The group in the trial

  • OmalizumabTreatment being tested

    Ex vivo exposure of excised human surgical polyp tissue to omalizumab.

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Record updated
13 August 2024