Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Recruiting
Phase 4
Interventional Study
Nasal Polyps
Staphylococcus Aureus
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 65
- Sex
- Any
- Trial phase
- Phase 4
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 20 (estimated)
- Sponsor
- University of Virginia · Other
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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 microbia…
Trial Locations
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Eligibility Criteria
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 c…
Contacts