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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06892704
Enrollment
30
Registered
2025-03-25
Start date
2025-05-01
Completion date
2027-12-31
Last updated
2025-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP), Smell Loss

Keywords

Dupilumab, Chronic Rhinosinusitis with Nasal Polyps, Smell Loss, Electrophysiology

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.

Interventions

24 weeks of dupilumab 300mg q2 weeks

Sponsors

Sanofi
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Status change of the Brief Smell Identification Test26 weeksThe brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.

Countries

United States

Contacts

Primary ContactClinical Coordinator
aditi.agarwal@northwestern.edu312 6958182
Backup ContactBruce Tan, MD
btan@nm.org312 6958182

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026