Status:
RECRUITING
Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
Lead Sponsor:
Montefiore Medical Center
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
18-99 years
Brief 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 o...
Detailed Description
First, it will confirm the effectiveness of dupilumab in the treatment of CRSwNP in ethnic and racial minority patients who have traditionally been underrepresented in existing clinical trials of biol...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 15 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05246267
Start Date
February 15 2022
End Date
June 1 2026
Last Update
May 10 2024
Active Locations (1)
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1
Montefiore Medical Center
The Bronx, New York, United States, 10461