CompletedPhase 4

Mechanisms of Smell Improvement With Dupilumab.

United States60 participantsStarted 2023-08-10

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Volumetric Olfactory Cleft Opacification Based on CT.

Timeframe: Baseline and Week 12 (3 months post-treatment)

Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.

Timeframe: 3 months post-treatment

Change in Olfactory Cleft Mucus IL-13 Concentration

Timeframe: Baseline and Week 12 (3 months post-treatment)

Change in Lund-Kennedy Endoscopy Score.

Timeframe: 3 months post-treatment

Change in Overall Polyp Score From Sinonasal Endoscopy

Timeframe: Baseline and Week 12 (3 months post-treatment)

Trial details

NCT IDNCT05964465

SponsorMedical University of South Carolina

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-30

Results submitted2026-06-16

View on ClinicalTrials.gov More Chronic Rhinosinusitis With Nasal Polyps trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Volumetric Olfactory Cleft Opacification Based on CT.

Timeframe: Baseline and Week 12 (3 months post-treatment)

Change in Olfactory Cleft Endoscopy Score Based on Nasalendoscopy.

Timeframe: 3 months post-treatment

Change in Olfactory Cleft Mucus IL-13 Concentration

Timeframe: Baseline and Week 12 (3 months post-treatment)

Change in Lund-Kennedy Endoscopy Score.

Timeframe: 3 months post-treatment

Change in Overall Polyp Score From Sinonasal Endoscopy

Timeframe: Baseline and Week 12 (3 months post-treatment)