Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.

Northwestern University

Status: Enrolling

Conditions: Smell Loss; Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)

Treatments: Drug: Dupilumab - Standard Dose

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06892704

STU0022296

Details and patient eligibility

About

The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:

1. Does obstruction of the olfactory cleft predict return of the sense of smell?
2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?

Participants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• Well documented history of CRSwNP
• BSIT age/sex classified as "abnormal" score
• Self-reported stable olfactory deficit of moderate to severe quality > 3 months
• Prior endoscopic sinus surgery >3 months, <10 years prior

Trial design

30 participants in 1 patient group

Dupilumab Treatment

Description:

Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab

Treatment:

Drug: Dupilumab - Standard Dose