Mechanisms of Smell Improvement With Dupilumab.

Medical University of South Carolina (MUSC)

Status and phase: Completed; Phase 4

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Dupilumab

Study type: Interventional

Funder types: Other

Identifiers

NCT05964465

Pro00125142

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Treatment

Experimental group

Description:

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.

Treatment:

Drug: Dupilumab