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

Ki vehet részt

• 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

Ki nem vehet részt

• 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