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Active, not recruiting

NCT Number: NCT05246267

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Rhinosinusitis With Nasal Polyps

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Montefiore Medical Center

The Bronx, New York, 10461, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 Eosinophilic granulomatosis with polyangiitis (EGPA)/Churg-Strauss Syndrome
  • Pregnant patients
  • Patients with inverted papilloma growth

Treatment and study plan

dupilumab

Biological

Standard of care treatment with dupilumab

Primary outcomes

  1. Change from baseline in Sino-Nasal outcome test (SNOT-22) score

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Change in sinonasal values from baseline will be assessed using the 22-item Sino-Nasal Outcome Test (SNOT-22). The SNOT-22 is a 22-item patient questionnaire used to measure symptom severity and related quality of life in people with chronic rhinosinusitis or nasal problems. Each of the 22 items is measured using a 6-point Likert scale ranging from 0 ("No problem") to 5 ("Worst possible problem"), yielding an overall scoring range of 0-110, such that higher scores are indicative of worsening symptom burden. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

  2. Change from baseline in Smell Function

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Change in smell function from baseline will be assessed using the University of Pennsylvania Smell Identification Test (UPSIT). The UPSIT is a standardized 40-item "scratch-and-sniff" test of olfactory function. Each participant is provided with four small booklets containing a total of 40 microencapsulated scent strips and is instructed to scratch the strip, sniff the odor, and pick the correct answer from a multiple-choice list of four options per item. Each correct identification of a scratch-and-sniff odor gives one point, yielding an overall possible scoring range of 1-40. Lower scores reflect a reduced ability to identify odors. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

  3. Change from baseline in Nasal Peak Flow (NPF)

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Change in NPF values from baseline will be evaluated in the clinic. Peak nasal inspiratory flow (PNIF) normal values typically range from 80-180 Liters per minute (L/min) in healthy adults, varying based on age, sex, and physical stature. Higher values are indicative of greater nasal airway patency. Change from baseline values will be expressed in units of L/min. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Secondary outcomes

  1. Change from baseline in urinary Leukotriene E4 (uLTE₄) levels

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Change in uLTE₄ levels from baseline will be assessed in the clinic. Urine samples will be collected during each specified timepoint, and samples will be processed and analyzed using liquid chromatography-tandem mass spectrometry (LC-MS/MS) or the appropriate immunoassay. Normal reference ranges for uLTE4 is ≤ 104 picograms per milligram (pg/mg) creatinine. Elevated uLTE₄ levels are indicative of heightened systemic or airway cysteinyl leukotriene activity and serve as a reliable, non-invasive biomarker for several inflammatory, respiratory, and hypersensitivity disorders. Change from baseline values will be expressed in units of pg/mg. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

  2. Change from Baseline in Absolute Peripheral Blood Eosinophil Count

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Changes in Absolute Eosinophil Count from peripheral blood from baseline will be assessed in the clinic. Blood samples will be drawn during each prespecified timepoint and analyzed using automated hematology analyzers or manual microscopy as part of a Complete Blood Count (CBC) with differential. Absolute Eosinophil Counts (AEC) vary by laboratory but are generally in the range of 0-500 cells per microliter (cells/µL) of blood. Elevated AEC in peripheral blood is indicative of increased in eosinophilic conditions as evident from rashes, worsening pulmonary symptoms and/or neuropathy. Change from baseline values will be expressed in cells/uL. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

  3. Change from Baseline in Serum Total Immunoglobulin E (IgE) Levels

    Time frame: Baseline, 2 weeks, 16 weeks, 36 weeks, and 52 weeks post-administration

    Changes in total serum IgE levels from baseline will be assessed in the clinic. Blood samples will be drawn during each prespecified timepoint and analyzed using automated immunoassay techniques to measure the concentration of circulating IgE. Standard reference ranges vary by laboratory assay, age, and individual baseline factors but are generally in the range of 0-100 International Units per milliliter (IU/mL) of blood. Elevated IGe concentrations can be indicative of a number of clinical indications including atopic and allergic diseases. Change from baseline values will be expressed in IU/mL. This outcome measure will only be assessed longitudinally in the participants receiving Dupilumab.

Interested in participating?

Active, not recruiting

This study is active but is not currently recruiting participants.

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Sponsors and collaborators

Lead sponsor

Montefiore Medical Center

Other

Collaborators

  • Mayo Clinic
  • Regeneron Pharmaceuticals

Registry information

Official study title

Dupilumab Treatment Effects in an Ethnically Diverse Population With Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP) Effect of 16-week Dupilumab Treatment on Sinonasal Respiratory Symptoms and Sense of Smell in Ethnically Diverse Patients With Chronic Rhinosinusitis and Nasal Polyposis (CRSwNP)

Acronym: CRSwNP

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Feb 18, 2022
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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