The Efficacy of XHANCE

Significant Improvement in Congestion1,2

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 are from NAVIGATE II and are consistent with the results seen in NAVIGATE I. Adult patients with nasal polyps and associated moderate-to-severe nasal congestion were enrolled and were randomized to receive placebo EDS (n=80), XHANCE 186 mcg BID (n=80), or XHANCE 372 mcg BID (n=82).1,2

 

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 evaluating patients with moderate-to-severe congestion and bilateral nasal polyps1-3

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: 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:

  • 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
  • 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.; 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. 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.

 

Significant Reduction in Bilateral Polyp Grade1,2

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

Baseline grade: placebo EDS, 3.8; XHANCE 186 mcg BID, 3.9; XHANCE 372 mcg BID, 3.8.

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.

POLYP GRADE CRITERIA

How polyps were graded in NAVIGATE I and NAVIGATE II

The bilateral polyp grade scale ranges from 0 (no polyp) to 6 (severe bilateral nasal polyposis). Baseline grade in NAVIGATE II: placebo EDS, 3.8; XHANCE 186 mcg BID, 3.9; XHANCE 372 mcg BID, 3.8.1

 
Animated illustration showing polyps classified as grade 1, 2, and 3
 

Polyp grade was determined by using nasoendoscopy and was based on extent of polyp tissue mass at the moment of observation relative to unequally spaced anatomic landmarks in 1 dimension1-3:

  • 0=no polyps
  • 1=not below the inferior border of the middle turbinate
  • 2=below the inferior border of the middle turbinate but not the inferior border of the inferior turbinate
  • 3=below the lower inferior border of the inferior turbinate

 

References:
  1. 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.
  2. 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.
  3. Data on file. OptiNose US, Inc.

 

 

XHANCE improved other defining symptoms (secondary endpoints)2

Sense of Smell2

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

Pain/Pressure2

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

Rhinorrhea2

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).

 

NOTE: Multiplicity adjustments were not applied for secondary endpoints; therefore, results 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 evaluating patients with moderate-to-severe congestion and bilateral nasal polyps1-3

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: 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:

  • 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
  • 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.; 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. 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.

 

Polyp Elimination (Grade=0) in at Least One Nostril2 — Secondary Endpoint

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

 

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.

 

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 evaluating patients with moderate-to-severe congestion and bilateral nasal polyps1-3

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: 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:

  • 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
  • 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.; 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. 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.

 

Reduction in Sino-Nasal Outcome Test (SNOT-22) Scores — Secondary Endpoint2

Line graph showing the change in SNOT-22 score from Week 0 to Week 16Line graph showing the change in SNOT-22 score from Week 0 to Week 16
  • In medical literature, surgery has been reported to reduce SNOT-22 scores by 18 to 23 points from baseline4,5
  • In a clinical trial, XHANCE reduced SNOT-22 scores by ~21 points from baseline at Week 162

 

About SNOT-22

  • SNOT-22 is a 22-question assessment of symptoms, quality of life, and functioning
  • Patients answer 22 questions using a scale of 0 (“no problem”) to 5 (“problem as bad as can be”)
  • Responses are summed, and total score ranges from 0 to 1104
  • In the clinical trials for XHANCE, the mean baseline SNOT-22 score for all arms was ~502,6
  • A change of ~9 points in SNOT-22 scores is considered the minimal clinically important difference4,5

 

NOTE: Multiplicity adjustments were not applied for secondary endpoints; therefore, results 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 evaluating patients with moderate-to-severe congestion and bilateral nasal polyps1-3

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: 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:

  • 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
  • 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.; 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. 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.

 

Patient Global Impression of Change (PGIC) at Week 16 — Secondary Endpoint2

Bar graph showing the percentage of patients who reported PGIC of “much improved” or “very much improved” at Week 16Bar graph showing the percentage of patients who reported PGIC of “much improved” or “very much improved” at Week 16

~68% of patients reported a Patient Global Impression of Change (PGIC) of “much improved” or “very much improved”2

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.”

 

NOTE: Multiplicity adjustments were not applied for secondary endpoints; therefore, results 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 evaluating patients with moderate-to-severe congestion and bilateral nasal polyps1-3

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: 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:

  • 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
  • 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.; 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. 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.

 

Review details of NAVIGATE I in the American Journal of Rhinology and Allergy.

Review details of NAVIGATE II in the Journal of Allergy and Clinical Immunology.

 

NOTE: These scientific publications contain additional outcome measures and other information, including exploratory endpoints, not contained in the full Prescribing Information, which are subject to important limitations.

View endoscopy videos taken before and after treatment with XHANCE.
See what makes XHANCE different.