Actively Recruiting
Interleukin-4Ralpha Blockade by Dupilumab Decreases Staphylococcus Aureus Colonization and Increases Microbial Diversity in Chronic Rhinosinusitis With Nasal Polyposis
Led by University of Virginia · Updated on 2025-04-01
20
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
Sponsors
U
University of Virginia
Lead Sponsor
R
Regeneron Pharmaceuticals
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to evaluate how the drug dupilumab affects patients with chronic rhinosinusitis with nasal polyposis (CRSwNP) who have sinus colonization with Staphylococcus aureus. CRSwNP is a chronic inflammatory condition linked to a high presence of type 2 inflammation and frequent colonization by Staph bacteria, which can worsen symptoms. Researchers want to see if dupilumab can reduce Staph colonization and improve the variety of microbes in the sinuses, which may also relate to better immune responses and symptom improvement. Participants will receive dupilumab 300 mg via prefilled syringe as treatment. The study focuses on patients who test positive for Staphylococcus aureus in sinus cultures. The treatment period is 16 weeks, during which researchers will observe changes in Staph abundance and microbial diversity. Dupilumab is being studied for its ability to block interleukin-4 receptor alpha, a key factor in the inflammatory cycle of CRSwNP. During the study, participants will have sinus cultures taken at the start and monitored over the 16 weeks to measure Staph levels and microbial diversity. The study will also assess antimicrobial protein expression and inflammation markers, along with clinical symptoms like smell function and questionnaire responses. Safety and treatment effects will be followed throughout, with the primary outcome focused on the reduction of Staphylococcus aureus at 16 weeks.
CONDITIONS
Brief Title
Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults, ages 18-65
- History of chronic rhinosinusitis with nasal polyposis (CRSwNP), including aspirin-exacerbated respiratory disease (AERD)
- Positive sinonasal culture showing Staphylococcus aureus at the first visit
- History of functional endoscopic sinus surgery (FESS) with open sinus passages allowing culture and tissue sampling
- Well-controlled asthma if present
- Well-controlled atopic dermatitis if present
- Use of nasal saline irrigation and stable topical corticosteroid dosing for more than 1 month allowed
- Physician intent to start dupilumab as part of standard care
- Meets FDA criteria for dupilumab use in nasal polyps
You will not qualify if you...
- Serious concurrent medical problems
- Uncontrolled asthma (Asthma Control Test score below 20 at screening)
- Use of oral corticosteroids within 60 days prior to screening
- Recent urgent care, emergency, or hospital visit for asthma within 60 days
- Current smoker or history of more than 10 pack-years smoking
- Use of biologic therapies, including for asthma, within the last 3 months
- Changes in chronic rhinosinusitis treatment within 1 month prior to screening
- Upper respiratory infection within 6 weeks prior to screening
- Antibiotic use within 6 weeks prior to screening
- Pregnant or breastfeeding women
- Any known allergy or contraindication to dupilumab including previous hypersensitivity reactions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive dupilumab treatment to decrease Staphylococcus aureus colonization and improve microbial diversity in chronic rhinosinusitis with nasal polyposis.
Regular visits during treatment as per protocol
Trial Site Locations
Total: 1 location
1
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Actively Recruiting
Research Team
K
Kristin W Wavell Shifflett, BS
D
Deborah Murphy, BSN
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here