Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
- Conditions
- Chronic Rhinosinusitis With Nasal Polyps
- Interventions
- Biological: Dupilumab
- Registration Number
- NCT05246267
- Lead Sponsor
- Montefiore Medical Center
- 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
- 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 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 60
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study group Dupilumab Patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab.
- Primary Outcome Measures
Name Time Method Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome at 2, 16, 36, and 52 weeks of treatment Measure changes in SNOT-22 values from baseline
Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values at 2, 16, 36, and 52 weeks of treatment Measure changes in UPSIT scores from baseline
Change in nasal peak flow (NPF) value (L/min) at 2, 16, 36, and 52 weeks of treatment Measure changes in the NPF values from baseline
- Secondary Outcome Measures
Name Time Method Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L at 2, 16, 36, and 52 weeks of treatment Measure changes in uLTE4 levels from baseline
Change in peripheral blood eosinophil counts in k/uL at 2, 16, 36, and 52 weeks of treatment Measure changes in peripheral blood eosinophil counts from baseline
Change in Immunoglobulin E (IgE) level in IU/mL at 2, 16, 36, and 52 weeks of treatment Measure changes in IgE levels from baseline
Trial Locations
- Locations (1)
Montefiore Medical Center
🇺🇸Bronx, New York, United States