Actively Recruiting
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
Eligibility Criteria
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
You will not qualify if you...
- None specified in the eligibility criteria
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
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
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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