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

Montefiore Medicine Academic Health System

Status: Enrolling

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Biological: Dupilumab

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05246267

2021-13161

Details and patient eligibility

About

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

Full 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 biologics in CRSwNP Second, this research will establish a biomarker of therapeutic response to dupilumab identifying the biological effect of dupilumab in CRSwNP patients and its association with symptom improvement.

Finally, the investigators will measure the effect of dupilumab on asthma symptoms and lung function in patients with CRSwNP and comorbid asthma.

There will be a screening visit, followed by a baseline visit where the medication will be given. Follow-up visits will be scheduled at 2 weeks and then 16 weeks from baseline. Long-term visits will take place in 36 and 52 weeks.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Study group

Description:

Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.

Treatment:

Biological: Dupilumab