Improvement in congestion and other defining nasal symptoms

The efficacy of XHANCE was evaluated in NAVIGATE I and NAVIGATE II: Two similar Phase 3 pivotal randomized, placebo-controlled, multicenter studies (n=646).1,2

Congestion ? Coprimary Endpoint1,2

Line graph showing the least-squares mean change in congestion score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in congestion score vs baseline for XHANCE and placebo

*Least-squares mean change from baseline in patient-reported AM instantaneous diary scores for nasal symptoms on a scale from 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Results shown above are from NAVIGATE II and are consistent with results observed in patients participating in NAVIGATE I.1,3

The comparator used in the pivotal clinical studies was a liquid placebo delivered with an Optinose Exhalation Delivery System (EDS).1

 

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.

 

Statistically significant onset of action was generally observed within 2 weeks for congestion score.1

Sense of Smell – Secondary Endpoint2‡

Line graph showing the least-squares mean change in sense of smell score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in sense of smell score vs baseline for XHANCE and placebo

Pain and Pressure – Secondary Endpoint2‡

Line graph showing the least-squares mean change in pain and pressure score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in pain and pressure score vs baseline for XHANCE and placebo

Rhinorrhea ? Secondary Endpoint2‡

Line graph showing the least-squares mean change in rhinorrhea score vs baseline for XHANCE and placebo
Line graph showing the least-squares mean change in rhinorrhea score vs baseline for XHANCE and placebo

*Least-squares mean change from baseline in patient-reported AM instantaneous diary scores for nasal symptoms on a scale from 0-3 (0 = none, 1 = mild, 2 = moderate, 3 = severe).

Results shown above are from NAVIGATE II and are consistent with results observed in patients participating in NAVIGATE I.1,3

‡Multiplicity adjustments were not applied for secondary endpoints; therefore, results require cautious interpretation and could potentially represent chance findings.

 

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.