Reduction in bilateral polyp grade
Mean Change in Bilateral Polyp Grade
Coprimary Endpoint – Week 161,2*
Baseline grade: placebo EDS, 3.8; XHANCE 186 mcg BID, 3.9; XHANCE 372 mcg BID, 3.8. Results shown above are from NAVIGATE II and are consistent with results observed in 242 additional patients participating in NAVIGATE I.1,3
The comparator used in the pivotal clinical studies was a liquid placebo delivered with an Optinose Exhalation Delivery System (EDS).1
Polyp Elimination (Grade=0) in at Least One Nostril Secondary Endpoint2*
*Multiplicity adjustments were not applied for secondary endpoints; therefore, results require cautious interpretation and could potentially represent chance findings. Furthermore, open-label results may be confounded by evaluator bias.
- Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
- Leopold DA, Elkayam D, Messina JC, et al. NAVIGATE II: randomized double-blind trial of the exhalation delivery system with fluticasone (EDS-FLU) for nasal polyposis. J Allergy Clin Immunol. 2018; In press.
- Data on file. OptiNose US, Inc.