About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
None
Trial population
Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.
Trial design
Cohort
Prospective
Treatments tested in this trial
Dupilumab - Standard Dose
Drug24 weeks of dupilumab 300mg q2 weeks
Treatment groups
Trial outcomes
Primary outcomes
Status change of the Brief Smell Identification Test
The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.
Sponsors and contacts
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Northwestern University
Lead sponsor
Sanofi
Collaborator