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

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT06892704
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
May 1, 2025
Status verified
May 2025
Primary completion
Apr 30, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
30 participants (estimated)

Arms

  • Arm: Dupilumab Treatment
    Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab

Primary Outcome Measure

Status change of the Brief Smell Identification Test [ Time Frame: 26 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern University Feinberg School of MedicineChicagoIllinois60611
Aditi Agarwal, MBBS, MSCI
[email protected]
312-695-8182
Bruce Tan, MD MS
[email protected]
312 6958182
Bruce Tan, MD, MS (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University Feinberg School of Medicine· Chicago, IL

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