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 trial design & details

XHANCE is a corticosteroid indicated for the treatment of nasal polyps in patients 18 years of age or older.

XHANCE has been extensively studied in over 1500 patients.1-5

646 patients with bilateral nasal polyps evaluated for efficacy and safety for up to 24 weeks2,3

  • NAVIGATE I and NAVIGATE II were double-blind, placebo-controlled trials lasting 16 weeks with an 8-week open-label extension in patients with bilateral nasal polyps and moderate to severe congestion. All patients received XHANCE 372 mcg BID during the open-label extension1-3

928 patients with chronic sinusitis with and without nasal polyps in 2 open-label trials evaluated for safety for up to 12 months1,4

  • EXHANCE-3 and EXHANCE-12 were open-label studies lasting 3 months (n=705) and 12 months (n=223)1,4
 
   
 

NAVIGATE I and NAVIGATE II: Phase 3 trials evaluating efficacy and safety

Two similar randomized, placebo-controlled, multicenter studies to assess XHANCE safety and efficacy (n=646)1

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: EDS-placebo, n=82; XHANCE 186 mcg BID, n=80; XHANCE 372 mcg BID, n=80. NAVIGATE II: EDS-placebo, n=79; XHANCE 186 mcg BID, n=80; XHANCE 372 mcg BID, n=82.1

Coprimary endpoints1:

  • Improvement in nasal congestion/obstruction at Week 4
  • Reduction in bilateral polyp grade at Week 16

Secondary endpoints include2,3:

  • Change from baseline in sense of smell, rhinorrhea, and facial pain or pressure
  • Subject assessment of Patient Global Impression of Change (PGIC) at Week 16
  • Change in Sino-Nasal Outcome Test-22 (SNOT-22) scores at Week 16
NOTE: Multiplicity adjustments were not applied for secondary endpoints; therefore, results could potentially represent chance findings. Furthermore, open-label results may be confounded by evaluator bias

Key inclusion criteria1:

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

Details2,3,5:

  • The comparator used in the pivotal clinical studies was a liquid placebo delivered with an Optinose Exhalation Delivery System (EDS)
  • 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

EXHANCE-3 and EXHANCE-12: Phase 3 open-label studies

Data demonstrating safety for up to 1 year were also evaluated in 2 open-label studies in 928 patients with chronic sinusitis (CS) with or without nasal polyps.1,4*

Graphic showing EXHANCE-3 and EXHANCE-12 study design Graphic showing EXHANCE-3 and EXHANCE-12 study design

Key inclusion criteria4:

  • CS with or without nasal polyps*
  • Experiencing ≥2 defining symptoms of CS

*XHANCE is not indicated to treat CS.

References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2023.
  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. 2019;143(1):126-134.
  3. Sindwani R, Han JK, Soteres DF, et al. NAVIGATE I: randomized, placebo-controlled, double-blind trial of the Exhalation Delivery System with fluticasone for chronic rhinosinusitis with nasal polyps. Am J Rhinol Allergy. 2019;33(1):69-82.
  4. 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;8(8):869-876.
  5. 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.