Reduction in bilateral polyp grade

Mean Change in Bilateral Polyp Grade
Coprimary Endpoint – Week 161,2*

Line graph showing the least-squares mean change in bilateral polyp grade for XHANCE and placebo
Line graph showing the least-squares mean change in bilateral polyp grade for XHANCE and placebo

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


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.

 


 

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*

Bar graph showing the percentage of patients who achieved polyp elimination in at least one nostril
Bar graph showing the percentage of patients who achieved polyp elimination in at least one nostril

*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.


See how XHANCE impacted Sino-Nasal Outcome Test-22 (SNOT-22) scores.
References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  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.
  3. Data on file. OptiNose US, Inc.