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

Part of paid clinical trials in The Bronx, New York.

Sponsor
Montefiore Medical Center
Study ID
NCT05246267
Status
Recruiting

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Dupilumab — BIOLOGICAL
    Standard of care treatment with dupilumab

Study Details

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

Key Dates

Start date
Feb 15, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
60 participants (estimated)

Arms

  • Arm: Study group
    Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.

Primary Outcome Measure

Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome [ Time Frame: at 2, 16, 36, and 52 weeks of treatment ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461
Golda Hudes, MD
866-633-8255
Golda Hudes, MD (PRINCIPAL_INVESTIGATOR)

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