XHANCE clinical trial design

XHANCE has been extensively studied in over 1500 patients.

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

  • NAVIGATE I and NAVIGATE II were double-blind, placebo-controlled trials lasting 16 weeks with an 8-week open-label extension2,3

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

XHANCE was studied in a patient population in which1:

  • 91% had reported previous use of a nasal steroid for the treatment of nasal polyps
  • 54% reported previous sinus surgery or polypectomy

NAVIGATE I and NAVIGATE II:
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
  • Change in Sino-Nasal Outcome Test-22 (SNOT-22) scores at Week 16
  • 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
Key inclusion criteria1,2:
  • Bilateral nasal polyps (grade 1 to 3)
  • Moderate-to-severe symptoms of nasal congestion/obstruction
Details1,2:
  • 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

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

EXHANCE-3 and EXHANCE-12: Phase 3 Open-Label Studies

Two studies in patients with CS with or without nasal polyps to assess XHANCE safety (n=928).2

Graphic showing EXHANCE-3 and EXHANCE-12 study design
Graphic showing EXHANCE-3 and EXHANCE-12 study design
Key inclusion criteria2:
  • CS with or without nasal polyps
  • Experiencing ≥2 defining symptoms of CS
Review the impact XHANCE had on congestion and other core nasal symptoms.
References:
  1. Full Prescribing Information for XHANCE (fluticasone propionate). OptiNose US, Inc.; 2017.
  2. Data on file. OptiNose US, Inc.
  3. 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.
  4. Palmer JN, Jacobson KW, Messina JC, Kosik-Gonzalez C, Djupesland PG, Mahmoud RA. EXHANCE-12: 1-year study of the exhalation delivery system with fluticasone (EDS-FLU) in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2018; In press.