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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorNorthwestern University

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Dupilumab - Standard Dose

    Drug

    24 weeks of dupilumab 300mg q2 weeks

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Dupilumab Treatment1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
26 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.