NCT05246267 Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
| NCT ID | NCT05246267 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Montefiore Medical Center |
| Condition | Chronic Rhinosinusitis With Nasal Polyps |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2026-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2022-02-15 with a primary completion date of 2026-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 of smell in a cohort of mostly ethnical and racial minority patients with CRSwNP
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
Contact & Investigator
Golda Hudes, MD
PRINCIPAL INVESTIGATOR
Montefiore Medical Center
Frequently Asked Questions
Who can join the NCT05246267 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Chronic Rhinosinusitis With Nasal Polyps. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05246267 currently recruiting?
Yes, NCT05246267 is actively recruiting participants. Contact the research team at ghudes@montefiore.org for enrollment information.
Where is the NCT05246267 trial being conducted?
This trial is being conducted at The Bronx, United States.
Who is sponsoring the NCT05246267 clinical trial?
NCT05246267 is sponsored by Montefiore Medical Center. The principal investigator is Golda Hudes, MD at Montefiore Medical Center. The trial plans to enroll 60 participants.