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

Recruiting

• Conditions: Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP); Smell Loss
• Interventions: Drug: Dupilumab - Standard Dose

• Registration Number: NCT06892704
• Lead Sponsor: Northwestern University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-19
• Study First Submitted QC: 2025-03-19
• Study First Posted: 2025-03-25
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-12
• Last Update Posted: 2025-05-14
• Primary Completion: 2027-04-30
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dupilumab Treatment	Dupilumab - Standard Dose	Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab

Primary Outcome Measures

Name	Time	Method
Status change of the Brief Smell Identification Test	26 weeks	The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States