RECRUITING

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

Conditions

Chronic Rhinosinusitis With Nasal Polyps CRSwNP dupilumab

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-02-15

Study Completion:2026-06

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05246267

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 99 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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"	* 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

Inclusion Criteria

Exclusion 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"

* 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

Contacts and Locations

Study Contact

Golda Hudes, MD

CONTACT

866-633-8255

ghudes@montefiore.org

Principal Investigator

Golda Hudes, MD

PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Study Locations (Sites)

Montefiore Medical Center

Bronx, New York, 10461

United States

Collaborators and Investigators

Sponsor: Montefiore Medical Center

Golda Hudes, MD, PRINCIPAL_INVESTIGATOR, Montefiore Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-02-15

Study Completion Date2026-06

Study Record Updates

Study Start Date2022-02-15

Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

CRSwNP
dupilumab

Additional Relevant MeSH Terms

Chronic Rhinosinusitis With Nasal Polyps