Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Key facts
- Who runs it
- University of Virginia
- Where
- Charlottesville, United StatesSee the site
- Trial code
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 20 people, planned
- Started
- 1 Sept 2022
- Expected to end
- 31 Dec 2026
- Type of study
- Interventional
- Treatments tested
- Dupilumab Prefilled Syringe
- Record updated
- 1 April 2025
Who can take part
- Age
- 18 years to 65 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 19 criteriaShow less
Who can take part
- 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
Who cannot take part
- Concurrent serious medical problem
- Recent (within 60 days) use of oral corticosteroids
- 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)
- Any contraindication to the use of dupilumab including hypersensitivity on previous administration
- Recent (within 6 weeks) upper respiratory infection
- Uncontrolled asthma (ACT <20 at screening visit)
- Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma
- Current smoker or has smoked >10 pack-years
- Antibiotics within 6 weeks
- Pregnant or breast-feeding women
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Where in United States
- University of Virginia Health SystemCharlottesville, United StatesContact: Deb Murphy, BSNTaking people
About the trial
What the trial wants to find out
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.
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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.
The group in the trial
- Dupilumab treatmentTreatment being tested
Treatment with dupilumab to demonstrate decreased staph prevalence and improve microbial diversity
Treatment: Dupilumab Prefilled Syringe
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Interleukin-4Ralpha Blockade by Dupilumab Decreases Staphylococcus Aureus Colonization and Increases Microbial Diversity in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
- Fit questions
- Built from NCT05094570, who can take part
- Record updated
- 1 April 2025