Blocking Interleukin-4Ra with Dupilumab to Reduce Staphylococcus in Nasal Polyps
Interleukin-4Ralpha Blockade by Dupilumab Decreases Staphylococcus Aureus Colonization and Increases Microbial Diversity in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)
This study is testing if a medication called dupilumab can help people with nasal polyps reduce harmful bacteria and improve their overall nasal health.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | University of Virginia Academic / other |
| Drugs / interventions | dupilumab |
| Locations | 1 site (Charlottesville, Virginia) |
| Trial ID | NCT05094570 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-65 with a history of chronic rhinosinusitis with nasal polyposis and confirmed Staphylococcus aureus colonization.
Not a fit: Patients with uncontrolled asthma, recent serious medical issues, or those who have recently used oral corticosteroids may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from chronic rhinosinusitis with nasal polyps by reducing bacterial colonization and enhancing nasal health.
How similar studies have performed: Other studies have shown promising results with similar approaches targeting type 2 inflammation in chronic rhinosinusitis, suggesting potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion 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 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 this trial is running
Charlottesville, Virginia
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.