RecruitingNCT05246267

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

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


Sponsor

Montefiore Medical Center

Enrollment

60 participants

Start Date

Feb 15, 2022

Study Type

OBSERVATIONAL

Conditions

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


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria4

  • 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 Criteria9

  • 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

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Interventions

BIOLOGICALDupilumab

Standard of care treatment with dupilumab


Locations(1)

Montefiore Medical Center

The Bronx, New York, United States

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NCT05246267


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