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

May 12, 2025 updated by: Northwestern University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Bruce Tan, MD
  • Phone Number: 312 6958182
  • Email: btan@nm.org

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University Feinberg School of Medicine
        • Contact:
        • Contact:
          • Bruce Tan, MD MS
          • Phone Number: 312 6958182
          • Email: btan@nm.org
        • Principal Investigator:
          • Bruce Tan, MD, MS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dupilumab Treatment
Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab
Drug: Dupilumab - Standard Dose
24 weeks of dupilumab 300mg q2 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Status change of the Brief Smell Identification Test
Time Frame: 26 weeks
The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.
26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

Sanofi

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 30, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

March 19, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 14, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU0022296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

IPD underlying publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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