Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-99
SponsorMontefiore Medical Center
About this trial
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
This trial does not accept healthy volunteersQualifiers
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"
Disqualifiers
Age under 18
Suspected or diagnosed allergic fungal rhinosinusitis.
Suspected or diagnosed cystic fibrosis.
Dupilumab coverage denied through insurance or "Dupixent MyWay Program"
Trial population
60 patients with physician-diagnosed CRSwNP, with or without comorbid asthma that meet indication criteria for FDA-approved use of Dupilumab. These patients will be 18 years and older and will have insurance that allows Dupilumab coverage or Dupilumab coverage obtained through "Dupixent MyWay Program"
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Dupilumab
Biological/VaccineStandard of care treatment with dupilumab
Treatment groups
60 Participants
are divided into 1 treatment groupGroup A: Study group1 intervention
Trial outcomes
Primary outcomes
1
Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome
Measure changes in SNOT-22 values from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatment2
Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values
Measure changes in UPSIT scores from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatment3
Change in nasal peak flow (NPF) value (L/min)
Measure changes in the NPF values from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatmentSecondary outcomes
1
Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L
Measure changes in uLTE4 levels from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatment2
Change in peripheral blood eosinophil counts in k/uL
Measure changes in peripheral blood eosinophil counts from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatment3
Change in Immunoglobulin E (IgE) level in IU/mL
Measure changes in IgE levels from baseline
Time frame
at 2, 16, 36, and 52 weeks of treatmentSponsors and contacts
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Source ClinicalTrials.gov