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
Active Not Recruiting

Conditions

  • Chronic Rhinosinusitis With Nasal Polyps

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
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

First listed
Feb 18, 2022
Start date
Feb 15, 2022
Status verified
Sep 2026
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
60 participants (actual)

Arms

  • Arm: CRSwNP participants receiving dupilumab
    Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
  • Arm: Non-CRSwNP surgical controls
    Patients undergoing sinonasal surgery for septal deviation, facial trauma with sinus fracture, cerebrospinal fluid (CSF) rhinorrhea, or sinonasal tumor. Single tissue collection at the time of surgery. No dupilumab administered. No subsequent study visits.

Primary Outcome Measure

Change from baseline in Sino-Nasal outcome test (SNOT-22) score [ Time Frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration ]

Locations (1)

FacilityCityStateZIPSite coordinators
Montefiore Medical CenterThe BronxNew York10461-

Find similar trials in The Bronx, NY

By research site
Montefiore Medical Center· The Bronx, NY

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