About this trial
Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity.
Primary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment.
Secondary Objectives will be to correlate reduction in Staph aureus abundance and improved bacterial diversity with increased expression of anti-microbial proteins (ß-defensins1-4) and cathelicidin LL-37. In addition, the investigators will correlate improvements in microbial diversity/decreased staph abundance with clinical improvements as assessed via questionnaires and objective/subjective smell function and also as improvements in cellular/immune T2 inflammation as assessed by reduced expression of T2 cytokines/chemokines and eosinophil/eosinophil-derived proteins.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Dupilumab Prefilled Syringe
Treatment groups
Sponsors and collaborators
University of Virginia
Lead sponsor
Regeneron Pharmaceuticals
Collaborator