90% of patients using XHANCE reported overall symptom improvement via PGIC

Patient Global Impression of Change (PGIC) at Week 16 Secondary Endpoint1,2*

Bar graph showing the percentage of patients who reported PGIC of 'worse', 'no change,' or 'improved' at Week 16
Bar graph showing the percentage of patients who reported PGIC of 'worse', 'no change,' or 'improved' at Week 16


XHANCE clinical trial design

XHANCE has been extensively studied in over 1600 patients

Phase 3 Trials Demonstrating Efficacy and Safety
Two similar randomized, placebo-controlled multicenter studies to assess XHANCE safety and efficacy (N=646).1,2

Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II Flow chart showing the study design and clinical trial format for NAVIGATE I and NAVIGATE II

NAVIGATE I: placebo EDS, n = 82; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 80.
NAVIGATE II: placebo EDS, n = 80; XHANCE 186 mcg BID, n = 80; XHANCE 372 mcg BID, n = 82.

Coprimary endpoints1,2:

  • Reduction of nasal congestion/obstruction symptoms at Week 4
  • Reduction in total polyp grade at Week 16

Secondary endpoints include1,2:

  • Change from baseline in nasal congestion/obstruction, sense of smell, rhinorrhea, and facial pain or pressure
  • Subject assessment of Patient Global Impression of Change (PGIC) at Week 16
  • Secondary endpoints were not controlled for Type I error

Key inclusion criteria1,2:

  • Bilateral nasal polyps (grade 1 to 3)
  • Moderate to severe symptoms of nasal congestion/obstruction

Details1,2:

  • A liquid placebo comparator was delivered using an Optinose Exhalation Delivery System (EDS)
  • In the pivotal clinical trials, 91% of patients reported previous use of a nasal steroid for the treatment of nasal polyps, and 54% reported previous sinus surgery or polypectomy
  • Patients and physicians remained blinded to initial treatment throughout the 8-week open-label extension
  • Patients with history of allergic rhinitis could participate in the study provided their “season” did not coincide with the first 4 weeks of the study
  • Subjects were allowed to use nonsedating antihistamines as “rescue” after Week 4 in an effort to reduce placebo dropout

 

References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  2. Data on file. OptiNose US, Inc.

 


 

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

See the XHANCE safety data from clinical trials.
Reference:
  1. Data on file. OptiNose US, Inc.
  2. 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.