Phase
Condition
Polyps
Sinusitis
Sinus Infections
Treatment
Omalizumab
Clinical Study ID
Ages 18-100 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Sinonasal inflammation for greater than 12 weeks which include at least 2 of thefollowing symptoms: nasal obstruction/congestion, nasal discharge (anterior orposterior), facial pressure/pain, reduction of sense of smell
Confirmation of the clinical symptoms by (2a) CT scan evidence of paranasal sinusmucosal inflammation, and/or (2b) endoscopic exam evidence of purulence from thesinuses 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.
Exclusion
Exclusion Criteria:
Children under the age of 18 will be excluded
No pregnant or lactating females, prisoners, mentally disabled, or persons unable togive informed consent will be contemplated for inclusion.
The subject groups will also exclude those with disease secondary to a clearlydefined anatomic process, such as facial trauma, and obstruction due to sinonasalneoplasm.
To eliminate confounding variables in our ex vivo experimental studies, any subjectwith a history of exposure to oral or systemic IV glucocorticoids within 2 weeks ofsurgery or any immunomodulatory biologics will be excluded. These include, but arenot limited to systemic treatment with biologics omalizumab, dupilumab, mepolizumab,benralizumab, reslizumab, or rituximab.
Study Design
Study Description
Connect with a study center
Johns Hopkins Bayview Medical Center
Baltimore, Maryland 21117
United StatesSite Not Available
Johns Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
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