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

Launched by MONTEFIORE MEDICAL CENTER · Feb 8, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dupilumab on patients with chronic rhinosinusitis with nasal polyps (CRSwNP). The goal is to see if adding dupilumab to standard treatments, like nasal corticosteroids, can help improve how patients feel about their symptoms and their sense of smell. The trial is focused on a diverse group of patients, particularly from different ethnic and racial backgrounds.

To be eligible for this study, participants need to be at least 18 years old and have a diagnosis of CRSwNP, with or without asthma. They should also be willing to consent to participate and have insurance that covers dupilumab or have access to the Dupixent MyWay Program for assistance. During the trial, participants will receive dupilumab alongside their usual treatments and will be asked about their symptoms and experiences. It's important to note that some individuals, such as those with certain other medical conditions or who are pregnant, may not be able to join the study.

Gender

ALL

Eligibility criteria

• 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