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
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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RECRUITING
30 participants
OBSERVATIONAL
2025-05-01
2027-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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COHORT
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
24 weeks of dupilumab 300mg q2 weeks
Interventions
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Dupilumab - Standard Dose
24 weeks of dupilumab 300mg q2 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Northwestern University
OTHER
Responsible Party
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Locations
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Northwestern University Feinberg School of Medicine
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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STU0022296
Identifier Type: -
Identifier Source: org_study_id
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