90% of patients using XHANCE reported overall symptom improvement via PGIC
Patient Global Impression of Change (PGIC) at Week 16 Secondary Endpoint1,2*
PGIC is a commonly used method of assessing clinically important change. With PGIC, the qualitative assessment of meaningful change is determined by the patient using a 7-item scale ranging from “very much worse” to “very much improved.”
*Multiplicity adjustments were not applied for secondary endpoints; therefore, results require cautious interpretation and could potentially represent chance findings.
The comparator used in the pivotal clinical studies was a liquid placebo delivered with an Optinose Exhalation Delivery System (EDS).1
Results shown above are from NAVIGATE II and are consistent with results observed in patients participating in NAVIGATE I.1
- Data on file. OptiNose US, Inc.
- 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.