Actively Recruiting

Age: 18Years - 65Years
All Genders
ID06892704

Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in Patients with Chronic Rhinosinusitis with Nasal Polyps

Led by Northwestern University ยท Updated on 2025-05-14

30

Participants Needed

1

Research Sites

35 weeks

Total Duration

On this page

Sponsors

N

Northwestern University

Lead Sponsor

S

Sanofi

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who experience smell loss. The study aims to find out whether blockage of the olfactory cleft and specific brain signals related to breathing and sniffing can predict the return of the sense of smell in patients treated with dupilumab. This is an observational study led by Northwestern University. Participants who have had prior sinus surgery for CRSwNP and continue to have smell loss will start dupilumab treatment at a standard dose of 300 mg every two weeks for 24 weeks. During this time, researchers will assess the degree of olfactory cleft obstruction and use electrophysiological tests to measure brain signals related to smell. Over six months of treatment, participants will be monitored for changes in their sense of smell using the Brief Smell Identification Test at 26 weeks. The study includes evaluations of olfactory cleft blockage and electrophysiological responses. Participants' smell function and related measurements will be tracked to understand factors predicting smell recovery while receiving dupilumab therapy.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Well documented history of chronic rhinosinusitis with nasal polyps (CRSwNP)
  • Abnormal Brief Smell Identification Test (BSIT) score based on age and sex
  • Stable moderate to severe self-reported smell loss lasting more than 3 months
  • Prior endoscopic sinus surgery performed more than 3 months and less than 10 years ago
Not Eligible

You will not qualify if you...

  • None specified in the eligibility criteria

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - 24 weeks

Participants receive dupilumab 300mg every 2 weeks for 24 weeks to assess olfactory restoration.

Approximately 12 visits (in-person) every 2 weeks

Trial Site Locations

Total: 1 location

1

Northwestern University Feinberg School of Medicine

Chicago, Illinois, United States, 60611

Actively Recruiting

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Research Team

C

Clinical Coordinator

B

Bruce Tan, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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