Mechanisms of Smell Improvement With Dupilumab.
Chronic Rhinosinusitis With Nasal Polyps
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps focused on measuring Chronic Rhinosinusitis, Nasal Polyps, dupilumab
Eligibility Criteria
Inclusion Criteria: Adults ≥18 years of age Meet criteria for CRSwNP as defined by ICAR-21 2 out of 4 cardinal symptoms for ≥12 weeks Visible evidence of inflammation on endoscopy or imaging Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side) Olfaction score ≥1 (0-3 scale) Candidate for treatment with dupilumab for CRSwNP Elected to proceed with dupilumab for treatment of CRSwNP Exclusion Criteria: Prior use of dupilumab Previous treatment with another biologic medication for CRSwNP or asthma within 6 months Any nasal or sinus surgery within the last 3 months Oral corticosteroid use within the last 1 month Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection; Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis; Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome; Kartagener syndrome; or dyskinetic cilia syndrome Poorly controlled asthma
Sites / Locations
- Medical University of South CarolinaRecruiting
- University of Virginia
Arms of the Study
Arm 1
Experimental
Treatment
The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.