Blocking Interleukin-4Ra with Dupilumab to Reduce Staphylococcus in Nasal Polyps

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of dupilumab, an interleukin-4 receptor antagonist, on patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) who are colonized with Staphylococcus aureus. The primary goal is to determine if dupilumab can decrease the abundance of Staphylococcus aureus while increasing microbial diversity in the sinonasal space. Secondary objectives include assessing the correlation between reduced Staphylococcus levels, improved microbial diversity, and enhanced expression of antimicrobial proteins, as well as evaluating clinical improvements through questionnaires and smell function tests. The study aims to address significant unmet medical needs in CRSwNP management.

Why it matters

Who can join: the full rules

Inclusion Criteria: • Adults, ages 18-65

* History of CRSwNP including subjects with AERD
* Sinonasal culture demonstrating staph aureus at visit 1
* History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus
* Asthma, if present, should be well controlled
* Atopic dermatitis, if present, should be well controlled
* Use of nasal saline irrigation and stable dosing (\>1 month) of topical corticosteroids is permitted
* Intent of the physicians caring to start dupilumab therapy as part of subject's standard of care
* Subject meets FDA approved criteria for the use of dupilumab for nasal polyps

Exclusion Criteria:

* Concurrent serious medical problem
* Uncontrolled asthma (ACT \<20 at screening visit)
* Recent (within 60 days) use of oral corticosteroids
* Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
* Current smoker or has smoked \>10 pack-years
* Biologic therapy including asthma biologic therapy in last 3 months
* Recent (within 1 month) change in CRS medical treatment (topical steroids, surfactants, irrigation protocol, etc. including changes in delivery volume or delivery methodology)
* Recent (within 6 weeks) upper respiratory infection
* Antibiotics within 6 weeks
* Pregnant or breast-feeding women
* Any contraindication to the use of dupilumab including hypersensitivity on previous administration

Where it's running

• University of Virginia Health System
  Charlottesville, Virginia, United States Recruiting

Study contacts

• Principal investigator: Larry C Borish, MD — University of Virginia
• Study coordinator: Kristin W Wavell Shifflett, BS
• Email: kww7d@virginia.edu
• Phone: 4349246874

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.