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

NCT06892704 | Recruiting FDA Drug

• 1 other identifier: STU0022296
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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. 1.Does obstruction of the olfactory cleft predict return of the sense of smell?
2. 2.Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?

Conditions

Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP); Smell Loss

Keywords

Dupilumab; Chronic Rhinosinusitis with Nasal Polyps; Smell Loss; Electrophysiology

Outcome Measures

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.

  26 weeks

Study Arms (1)

Dupilumab Treatment

Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab

Drug: Dupilumab - Standard Dose

Interventions

Dupilumab - Standard Dose DRUG

24 weeks of dupilumab 300mg q2 weeks

Dupilumab Treatment

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Northwestern University: lead
• Sanofi: collaborator

Study Sites (1)

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 60611, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Nasal secretions, Exhaled Breath Condensate, Tissue

MeSH Terms

Conditions

Anosmia

Interventions

dupilumab

Condition Hierarchy (Ancestors)

Olfaction Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Clinical Coordinator

CONTACT

312 6958182; aditi.agarwal@northwestern.edu

Bruce Tan, MD

CONTACT

312 6958182; btan@nm.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 19, 2025
• First Posted: March 25, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 30, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)