RecruitingNot Applicable

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis

United States60 participantsStarted 2022-02-15

Plain-language summary

The central hypothesis of this study is that the addition of dupilumab treatment onto standard-of-care intranasal corticosteroids will improve patient-reported measures of disease activity and sense of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP

Who can participate

Age range

18 Years – 99 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: * Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. * Patients aged 18 years and older. * Patient willing to provide consent to be a participant in the study. * Patients with insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program" Exclusion Criteria: * Age under 18 * Suspected or diagnosed allergic fungal rhinosinusitis. * Suspected or diagnosed cystic fibrosis. * Dupilumab coverage denied through insurance or "Dupixent MyWay Program" * Patients who required a steroid taper in the preceding 30 days. However, patients on chronic steroids less or equal to 20 mg of prednisone daily, are eligible. * Patients who were on a different biologic medication in the preceding 3 months. * Patients with a diagnosis of EGPA/Churg-Strauss Syndrome * Pregnant patients * Patients with inverted papilloma growth

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 Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome

Timeframe: at 2, 16, 36, and 52 weeks of treatment

Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values

Timeframe: at 2, 16, 36, and 52 weeks of treatment

Change in nasal peak flow (NPF) value (L/min)

Timeframe: at 2, 16, 36, and 52 weeks of treatment

Trial details

NCT IDNCT05246267

SponsorMontefiore Medical Center

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-06

Contact for this trial

Golda Hudes, MD

866-633-8255 ghudes@montefiore.org

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

Who can participate

Age range

18 Years – 99 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 Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome

Timeframe: at 2, 16, 36, and 52 weeks of treatment

Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values

Timeframe: at 2, 16, 36, and 52 weeks of treatment

Change in nasal peak flow (NPF) value (L/min)

Timeframe: at 2, 16, 36, and 52 weeks of treatment