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

NCT ID: NCT06892704

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) Smell Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Dupilumab Treatment

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

Dupilumab - Standard Dose

Intervention Type DRUG

24 weeks of dupilumab 300mg q2 weeks

Interventions

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Dupilumab - Standard Dose

24 weeks of dupilumab 300mg q2 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Coordinator

Role: CONTACT

312 6958182

Bruce Tan, MD

Role: CONTACT

312 6958182

Facility Contacts

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Aditi Agarwal, MBBS, MSCI

Role: primary

312-695-8182

Bruce Tan, MD MS

Role: backup

312 6958182

Other Identifiers

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STU0022296

Identifier Type: -

Identifier Source: org_study_id

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