Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP

Launched by UNIVERSITY OF VIRGINIA · Oct 21, 2021

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a medication called dupilumab on patients with chronic rhinosinusitis with nasal polyps (CRSwNP) who have a specific type of bacteria known as Staphylococcus aureus living in their sinuses. Researchers believe that taking dupilumab can help reduce the amount of this bacteria and improve the variety of other healthy bacteria in the nose, which may lead to better overall health in the sinuses and improved smell.

To be eligible for the trial, participants need to be adults aged 18 to 65 who have a history of nasal polyps and have tested positive for Staphylococcus aureus in their sinuses. They should also have well-controlled asthma and atopic dermatitis, if relevant. During the trial, participants will receive dupilumab as part of their treatment, and researchers will monitor changes in their nasal bacteria, symptoms, and overall health. It’s important to note that certain conditions and recent medical treatments may exclude individuals from participating. This trial is currently recruiting participants, and it aims to provide valuable insights into how dupilumab can help those with CRSwNP.

Gender

ALL

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 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