Clinical trial NCT05246267: Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis
Official title: Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Keywords: CRSwNP
dupilumab
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2022-02-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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"

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.

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

Primary outcomes:
measure: Change in Sinonasal outcome test (SNOT-22) score, scale 0-110, higher is worse outcome
timeFrame: at 2, 16, 36, and 52 weeks of treatment
measure: Change in University of Pennsylvania Smell Identification Test (UPSIT) scores, scale 0-40, lower is worse outcome values
timeFrame: at 2, 16, 36, and 52 weeks of treatment
measure: Change in nasal peak flow (NPF) value (L/min)
timeFrame: at 2, 16, 36, and 52 weeks of treatment
Secondary outcomes:
measure: Change in urinary levels of Leukotriene E4 (uLTE4) levels in ug/L
timeFrame: at 2, 16, 36, and 52 weeks of treatment
measure: Change in peripheral blood eosinophil counts in k/uL
timeFrame: at 2, 16, 36, and 52 weeks of treatment
measure: Change in Immunoglobulin E (IgE) level in IU/mL
timeFrame: at 2, 16, 36, and 52 weeks of treatment
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Golda Hudes, MD
role: PRINCIPAL_INVESTIGATOR
References: