NAVIGATE II: Trial Details
Pivotal efficacy and safety data for XHANCE have been published in the Journal of Allergy and Clinical Immunology
NOTE: This scientific publication contains additional outcome measures and other information, including exploratory endpoints, not contained in the full Prescribing Information, which are subject to important limitations and require cautious interpretation.
NAVIGATE II was part of a comprehensive development program consisting of five clinical trials evaluating XHANCE in more than 1,500 adult patients, including two randomized, double-blind, placebo-controlled, Phase 3 pivotal clinical trials in adults with nasal polyposis (NAVIGATE I and NAVIGATE II) and two supportive open-label Phase 3 clinical trials in adults with symptoms of chronic sinusitis with or without nasal polyps (EXHANCE-3 and EXHANCE-12).1-4
In NAVIGATE II, use of XHANCE resulted in significant improvement in both coprimary outcome measures: congestion/obstruction at Week 4 and mean change in bilateral polyp grade at Week 16.1
- 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.
- Palmer JN, Jacobson KW, Messina JC, et al. EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018; In press.
- Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
- Data on file. OptiNose US, Inc.