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NCT Number: NCT06892704

Olfactory Cleft Obstruction and Electrophysiological 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.

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Key information

Conditions

Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP) Anosmia Nervous System Diseases Neurologic Manifestations Olfaction Disorders Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Smell Loss

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

Location status: Recruiting

Location contact

Aditi Agarwal, MBBS, MSCI

CONTACT

[email protected]

312 6958182

Bruce Tan, MD MS

CONTACT

[email protected]

312 6958182

Bruce Tan, MD, MS

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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

Treatment and study plan

Dupilumab - Standard Dose

Drug

24 weeks of dupilumab 300mg q2 weeks

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bruce Tan, MD

CONTACT

[email protected]

312 6958182

Clinical Coordinator

CONTACT

[email protected]

312 6958182

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 25, 2025
Registry last updated
Jul 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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