Mechanisms of Smell Improvement With Dupilumab.

NCT ID: NCT05964465

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-10
• Study Completion Date: 2025-01-30

Brief Summary

This study seeks to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with chronic sinusitis with nasal polyps (CRSwNP). The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation.

Detailed Description

Post-marketed administration of dupilumab (FDA approved medication for CRSwNP) in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP) will result in significant improvement in objective measures of olfactory cleft inflammation and psychophysical olfaction. The investigators seek to explore the mechanism through which dupilumab improves olfactory cleft inflammation in patients with CRSwNP. The investigators also want to determine whether change in olfactory cleft inflammation correlates with improvement in olfaction (one of the cardinal symptoms of CRSwNP) at 3 months. The investigators hypothesize that after 3 months of treatment with dupilumab, non-inflammatory factors will explain a significant degree of variation in residual clinical olfaction. Additionally, the investigators want to explore the determinants of ongoing olfactory loss after 3 months of treatment with attention to non-inflammatory factors. The investigators expect this study to provide convincing evidence that dupilumab improves clinical olfaction via direct reduction in olfactory cleft inflammation. Specifically, the investigators expect to show that reduction in olfactory cleft inflammation is the result of reduction in IL13 levels in olfactory cleft mucus. Finally, the investigators expect to show that most of the variation in post-treatment olfaction can be explained by non-inflammatory measures that are independent of CRSwNP.

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment

The treatment group will receive dupilumab at 300mg SC Q2weeks. The first dose will be administered via subcutaneous injection in clinic at baseline. Subjects will self-administer study drug (dupilumab 300 mg) subcutaneous every 2 weeks after initial dosing at visit 2.

Group Type: EXPERIMENTAL

Dupilumab

Intervention Type: DRUG

Monoclonal antibody blocking interleukin 4 and interleukin 13

Interventions

Dupilumab

Monoclonal antibody blocking interleukin 4 and interleukin 13

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Adults ≥18 years of age
• Meet criteria for CRSwNP as defined by ICAR-21
• 2 out of 4 cardinal symptoms for ≥12 weeks
• Visible evidence of inflammation on endoscopy or imaging
• Bilateral visible nasal polyps ≥1 in each nasal cavity (0-4 scale each side)
• Olfaction score ≥1 (0-3 scale)
• Candidate for treatment with dupilumab for CRSwNP
• Elected to proceed with dupilumab for treatment of CRSwNP

Exclusion Criteria

• Prior use of dupilumab
• Previous treatment with another biologic medication for CRSwNP or asthma within 6 months
• Any nasal or sinus surgery within the last 3 months
• Oral corticosteroid use within the last 1 month
• Current pregnancy, breast-feeding, or plan to become pregnant during next 3 months
• Presence of antrochoanal nasal polyps; acute rhinosinusitis; upper respiratory infection;
• Allergic granulomatous angiitis/eosinophilic granulomatosis with polyangiitis;
• Granulomatosis with polyangiitis; cystic fibrosis; Young syndrome;
• Kartagener syndrome; or dyskinetic cilia syndrome
• Poorly controlled asthma

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Shaun Nguyen

Professor and Director of Clinical Research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Other Identifiers

Pro00125142

Identifier Type: -

Identifier Source: org_study_id