FLONASE® SENSIMIST™ Allergy Relief Clinical Profile

 

FLONASE® SENSIMIST™ Allergy Relief Clinical Profile

FLONASE® SENSIMIST™ has been shown to provide
relief of the most bothersome allergy symptoms
including nasal congestion and itchy, watery eyes.*1

FLONASE® SENSIMIST™ has been proven safe in both
adult and pediatric populations.*2-13

*Ocular symptom relief indicated for patients aged 12 and older.

Nighttime Relief

Seasonal Nasal + Ocular Symptoms

Perennial Nasal Symptoms

Patient-preferred

Onset + Safety

Nighttime Relief Superior to Fexofenadine14

In 2 clinical studies, FLONASE® SENSIMIST™ was significantly better than Allegra® (fexofenadine) at reducing
Nighttime Symptoms Score (NSS).†14

Mean Change From Baseline in Nighttime
Symptoms Score by Treatment Day14

NSS comprises three areas related to nighttime allergies: difficulty going to sleep because of nasal symptoms, nighttime awakenings
due to nasal symptoms, and nasal congestion on waking. These are rated on a scale from 0 (not at all) to 3 (very much) and
combined to determine NSS.14

Clinically Proven To Relieve Seasonal Nasal Allergy Symptoms‡4-6,10

Total Nasal Symptom Score Reductions (TNSS) in Seasonal
Allergic Rhinitis Over 2 Weeks in Patients ≥12 Years of Age‡4,5

Nasal congestion, rhinorrhea, sneezing, nasal itching.

Clinically Proven To Relieve Seasonal Ocular Allergy Symptoms§4-6,10

Total Ocular Symptom Score Reductions (TOSS) in Seasonal
Allergic Rhinitis Over 2 Weeks in Patients ≥12 Years of Age§4-6,10

§Itchy/burning eyes, tearing/watering eyes, red eyes.

Clinically Proven To Relieve Perennial Nasal Allergy Symptoms||8,9,15

Total Nasal Symptom Score Reductions (TNSS) in Perennial
Allergic Rhinitis in Patients ≥12 Years of Age||8,9,15

||Study 1 was 6 weeks, studies 2 and 3 were 4 weeks.

Patients Appreciate the Gentle FLONASE® SENSIMIST™ Experience

In four studies, patient experience was assessed using the Product Characteristic Questionnaire¶,#16-19

FLONASE® SENSIMIST™

In 4 studies vs placebo, patient experience was assessed using the Product Characteristic Questionnaire. The Product Characteristic Questionnaire consisted of 6 questions pertaining to the experience with treatment, covering portability and acceptability of the device and perceptions of aftertaste, spray "run-off" following administration, and spray sensation.

#Percentages of patients in the top 2 categories (somewhat to extremely) who agreed with each statement.

Patients Prefer FLONASE® SENSIMIST™ Over Nasonex®20

In a single-dose, crossover, patient-preference study, patients reported a better experience with FLONASE® SENSIMIST™ than with Nasonex®

  • Over a 2-week period, patients’ satisfaction was 87% higher with FLONASE® SENSIMIST™ than Nasonex®**
  • Fewer subjects perceived a bitter taste with fluticasone furoate (P= 0.01)
  • Fewer subjects reported medication running down their throats with fluticasone furoate (P= 0.033)
  • Fewer subjects reported medication running out of their noses with fluticasone furoate (P= 0.002)
  • Nasonex® was more frequently reported to induce nasal irritation (P = 0.012), sneezing (P= 0.017), and rhinorrhea (P= 0.007) compared to fluticasone furoate

Nasonex® is a registered trademark of Merck & Co., Inc.
**In a multicenter, RCT, 48 SAR patients were administered both FFNS and MFNS for 2 weeks each in a crossover fashion. P<0.0003 vs MFNS.

Onset of Action

  • Onset of symptom relief occurs as early as 8 hours4,21

Safety in Adolescents and Adults

FLONASE® SENSIMIST™ has a well-established safety profile in both adults and pediatric patients and has been shown to have a low incidence of adverse events in both populations.4-13

 

RESOURCES

Patient education materials and more

PATIENT TYPES

Explore different patient types and find out which product is right for your patients

DOSING

Learn more about FLONASE® SENSIMIST™ Administration and Dosing

References

1. Fromer LM, Blaiss MS, Jabcob-Nara JA, et al. Current Allergic Rhinitis Experiences Survey (CARES): Consumers’ awareness, attitudes and practices. Allergy Asthma Proc. 2014;35:307-315. 2. GlaxoSmithKline. A randomized, double-blind, placebo-controlled, parallel-group, multicenter, study to evaluate the efficacy and safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg for 4 weeks in adult and adolescent subjects (≥12 years of age) with perennial allergic rhinitis (PAR). https://www.gsk-clinicalstudyregister.com/files2/20736.pdf. Updated March 6, 2008. Accessed November 2, 2016. 3. Data on file, GlaxoSmithKline. A randomized, double-blind, placebo-controlled, parallel-group, multi-center study to evaluate the efficacy and safety of once-daily, intranasal administration of GW685698X aqueous nasal spray 100mcg for 14 days in adult and adolescent subjects with seasonal allergic rhinitis. https://www.gsk-clinicalstudyregister.com/files2/20737.pdf. Updated March 6, 2008. Accessed November 2, 2016. 4. Kaiser HB, Naclerio RM, Given J, et al. Fluticasone furoate nasal spray: a single treatment option for the symptoms of seasonal allergic rhinitis. J Allergy Clin Immunol. 2007;119:1430-1437. 5. Fokkens WJ, Jogi R, Reinartz S, et al. Once daily fluticasone furoate nasal spray is effective in seasonal allergic rhinitis caused by grass pollen. Allergy. 2007;62:1078-1084 6. Jacobs R, Martin B, Hampel F, et al. Effectiveness of fluticasone furoate 110 μg once daily in the treatment of nasal and ocular symptoms of seasonal allergic rhinitis in adults and adolescents sensitized to mountain cedar pollen. Curr Med Res Opin. 2009;25(6):1393-1401. 7. Martin BG, Ratner PH, Hampel FC, et al. Optimal dose selection of fluticasone furoate nasal spray for the treatment of seasonal allergic rhinitis in adults and adolescents. Allergy Asthma Proc. 2007;28:216–225. (FFR20001) 8. Vasar M, Houle P-A, Douglass JA, et al. Fluticasone furoate nasal spray: effective monotherapy for symptoms of perennial allergic rhinitis in adults/adolescents. Allergy Asthma Proc. 2008;29(3):313-321. 9. Nathan RA, Berger W, Yang W, et al. Effect of once-daily fluticasone furoate nasal spray on nasal symptoms in adults and adolescents with perennial allergic rhinitis. Ann Allergy Asthma Immunol. 2008;100:497–505. (FFR30002) 10.  Avamys [product monograph]. Mississauga, Canada: GlaxoSmithKline Inc; 2015 11. Meltzer EO, Lee J, Tripathy I, et al. Efficacy and safety of once-daily fluticasone furoate nasal spray in children with seasonal allergic rhinitis treated for 2 wk. Pediatr Allergy Immunol.2009;20: 279–286. 12. Maspero JF, Rosenblut A, Finn Jr A, et al. Safety and efficacy of fluticasone furoate in pediatric patients with perennial allergic rhinitis. Otolaryngol Head Neck.  2008;138:30-37. 13. Tripathy I, Levy A, Ratner P, et al. HPA axis safety of fluticasone furoate nasal spray once daily in children with perennial allergic rhinitis. Pediatr Allergy Immunol. 2009;20:287–294. 14. Andrews CP, Martin BG, Jacobs RL, et al. Fluticasone furoate nasal spray is more effective than fexofenadine for nighttime symptoms of seasonal allergy. Allergy Asthma Proc. 2009;30(2):128-138. 15. GSK Clinical Study Register. Study 111439. Available at https://www.gsk-clinicalstudyregister.com/study/FFU111439?search=study&#csr. Accessed November 4, 2016. 16. GSK Clinical Study Register. Study FFR30002. Available at: http://www.gsk-clinicalstudyregister.com/study/FFR30002?search=study&#csr. Accessed October 19, 2016. 17. GSK Clinical Study Register. Study FFR30003. Available at: http://www.gsk-clinicalstudyregister.com/study/FFR30003?search=study&#csr. Accessed October 19, 2016. 18. GSK Clinical Study Register. Study FFR103184. Available at: http://www.gsk-clinicalstudyregister.com/study/FFR1013184?search=study&#csr. Accessed October 19, 2016. 19. GSK Clinical Study Register. Study FFR104861. Available at: http://www.gsk-clinicalstudyregister.com/study/FFR104861?search=study&#csr. Accessed October 19, 2016. 20. Yonezaki M, et al. Preference evaluation and perceived sensory comparison of fluticasone furoate and mometasone furoate intranasal sprays in allergic rhinitis. Auris Nasus Larynx. 2016;43(3):292-297. 21. Berkowitz RB, Bernstein DI, LaForce C. Onset of action of mometasone furoate nasal spray (NASONEX®) in seasonal allergic rhinitis. Allergy. 1999;54:64-69.