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Fluticasone Furoate∗ (FF) Nasal Spray-Development of a Next-Generation Delivery System for Allergic Rhinitis [∗USAN approved name]
Abstracts S231
J ALLERGY CLIN IMMUNOL VOLUME 119, NUMBER 1
Ocular Efficacy of a Novel, Enhanced Affinity Corticosteroid, Fluticasone Furoate* Nasal Spray, in Ragweed-Sensitive Patients *USAN-approved name W. R. Lumry1, S. H. Cohen2, A. Levy3, E. Philpot4, T. Toler4, A. Ellsworth4; 1Allergy and Asthma Specialists, Dallas, TX, 2Allergic Diseases, Milwaukee, WI, 3Foot Hills Asthma & Allergy Association, Spartanburg, SC, 4GlaxoSmithKline, Research Triangle Park, NC. RATIONALE: Inconsistent results have been reported for the ocular efficacy of nasally administered corticosteroids in treating seasonal allergic rhinitis (SAR). This study evaluated the effects of a novel, enhanced-affinity corticosteroid, fluticasone furoate nasal spray (FFNS), on ocular symptoms caused by ragweed. METHODS: Two hundred ninety-nine subjects (12 years) with confirmed ragweed SAR were randomized to double-blind treatment for two weeks with once-daily FFNS 110mcg or vehicle placebo administered in a unique, side-actuated device. Ocular efficacy was assessed by the mean change from baseline over the two-week treatment period in daily reflective Total Ocular Symptom Scores (rTOSS). Daily rTOSS was the average of the morning and evening rTOSS ratings of eye itching/burning, tearing/ watering, and redness, where each symptom was scored on a 0-3 scale (none to severe). Other ocular endpoints included the mean change from baseline in AM pre-dose, instantaneous (i)TOSS and the mean change from baseline in the individual eye symptoms. RESULTS: Baseline ocular assessments were similar for both groups. Least square (LS) mean change from baseline over the treatment period in daily rTOSS was significant for the FFNS 110mcg group (-2.23) compared with placebo (-1.63) (p50.004) confirming efficacy for these symptoms. FFNS also demonstrated a sustained ocular effect for 24 hours based on the LS mean change from baseline for the AM iTOSS (placebo, -1.30; FFNS 110mcg, -1.86; p50.007). Treatment differences for the three individual eye symptoms were also significant for FFNS (p0.044). CONCLUSIONS: Once-daily FFNS 110mcg demonstrated clinically significant, sustained 24-hour efficacy for the ocular symptoms associated with ragweed-induced seasonal allergic rhinitis. Funding: GlaxoSmithKline
907
Fluticasone Furoate* (FF) Nasal Spray-Development of a Next-Generation Delivery System for Allergic Rhinitis [*USAN approved name] W. Berger1, J. W. Godfrey2, A. C. Grant2, A. L. Slater2, S. J. Broughton2; 1 Southern California Research, Mission Viejo, CA, 2GlaxoSmithKline Research & Development, Ware, Hertfordshire, UNITED KINGDOM. RATIONALE: Market research with patients and clinicians identified several features of existing nasal sprays which make them difficult and unpleasant to use. METHODS: Engineering and design solutions were developed for the FF delivery system to improve patient experience. RESULTS: d Consistent dose A trigger mechanism was developed to minimise the potential variation in dose administration. d
The device remains ready to use
The lid was designed to assure that the device remains primed after first use. d Easier third party administration The unique, side-actuated design minimises movement of the nozzle within the nose during actuation and eliminates the need for care-giver’s fingers to be close to the patient’s nose. d
Patient comfort
A shorter nozzle is possible due to the side-actuated design. A low dose volume (50ml) is delivered as a fine mist to minimise the amount of
formulation available to run down the back of the throat or drip from the nostrils. d
Easily carried
The sturdy, plastic device provides additional protection to the inner container. Engineering features prevent accidental actuation when the lid is in place. In-vitro tests have confirmed that the device is robust and delivers a consistent dose, even when left unused for a period of 6 weeks. Patient comfort was evaluated in a Phase III clinical study (n5302) where 97% of patients found the drug product comfortable to use and 95% considered the product easy to carry. CONCLUSIONS: The novel delivery system developed for FF Nasal Spray addresses several shortcomings identified by patients and clinicians in existing products. Funding: GlaxoSmithKline
908
Once-daily Fluticasone Furoate* Nasal Spray (FF) Effectively Treats Ocular Symptoms Of Seasonal Allergic Rhinitis (SAR) Caused By Mountain Cedar Pollen *USAN Approved Name P. Ratner1, C. Andrews2, J. van Bavel3, T. Toler4, A. Ellsworth4, E. Philpot4; 1Sylvana Research Associates, San Antonio, TX, 2Diagnostics Research Group, San Antonio, TX, 3Allergy and Asthma Associates, Austin, TX, 4GlaxoSmithKline, Research Triangle Park, NC. RATIONALE: FF, a novel enhanced-affinity steroid, was evaluated for relief of both ocular and nasal SAR symptoms. METHODS: 302 subjects (12 years) allergic to mountain cedar pollen were randomized to once-daily FF 110mcg or placebo spray. Ocular endpoints included mean change from baseline (MCFB) over the entire 2week treatment period in daily reflective total ocular symptoms scores (rTOSS), and MCFB in morning pre-dose instantaneous total ocular symptoms scores (iTOSS). Total ocular scores were the sum of 3 symptoms: eye itching/burning; tearing/watering; and redness. The MCFB in daily reflective total nasal symptoms scores (rTNSS) was the primary endpoint. Data were analyzed using ANCOVA. RESULTS: FF 110mcg was significantly more effective than placebo for the MCFB in the rTOSS (p50.008) and the MCFB in morning pre-dose iTOSS (p50.009), indicating 24-hour ocular symptom efficacy. FF 110mcg also was significantly more effective on the MCFB in rTNSS (p50.003). No serious AEs were reported, and epistaxis, the most common drug-related AE, occurred in 7% and 5% of placebo and FF subjects, respectively, but only 3% of those in each group were considered drugrelated. CONCLUSIONS: This study demonstrated that, in addition to nasal symptom relief, once-daily FF 110 mcg showed efficacy for ocular symptoms in subjects with SAR. Although the mechanism of action remains to be determined, the efficacy of FF on ocular symptoms may involve modulation of allergen-induced increases in nasal neuronal activity leading to decreased symptoms. Funding: GlaxoSmithKline
MONDAY
906
J ALLERGY CLIN IMMUNOL VOLUME 119, NUMBER 1
Ocular Efficacy of a Novel, Enhanced Affinity Corticosteroid, Fluticasone Furoate* Nasal Spray, in Ragweed-Sensitive Patients *USAN-approved name W. R. Lumry1, S. H. Cohen2, A. Levy3, E. Philpot4, T. Toler4, A. Ellsworth4; 1Allergy and Asthma Specialists, Dallas, TX, 2Allergic Diseases, Milwaukee, WI, 3Foot Hills Asthma & Allergy Association, Spartanburg, SC, 4GlaxoSmithKline, Research Triangle Park, NC. RATIONALE: Inconsistent results have been reported for the ocular efficacy of nasally administered corticosteroids in treating seasonal allergic rhinitis (SAR). This study evaluated the effects of a novel, enhanced-affinity corticosteroid, fluticasone furoate nasal spray (FFNS), on ocular symptoms caused by ragweed. METHODS: Two hundred ninety-nine subjects (12 years) with confirmed ragweed SAR were randomized to double-blind treatment for two weeks with once-daily FFNS 110mcg or vehicle placebo administered in a unique, side-actuated device. Ocular efficacy was assessed by the mean change from baseline over the two-week treatment period in daily reflective Total Ocular Symptom Scores (rTOSS). Daily rTOSS was the average of the morning and evening rTOSS ratings of eye itching/burning, tearing/ watering, and redness, where each symptom was scored on a 0-3 scale (none to severe). Other ocular endpoints included the mean change from baseline in AM pre-dose, instantaneous (i)TOSS and the mean change from baseline in the individual eye symptoms. RESULTS: Baseline ocular assessments were similar for both groups. Least square (LS) mean change from baseline over the treatment period in daily rTOSS was significant for the FFNS 110mcg group (-2.23) compared with placebo (-1.63) (p50.004) confirming efficacy for these symptoms. FFNS also demonstrated a sustained ocular effect for 24 hours based on the LS mean change from baseline for the AM iTOSS (placebo, -1.30; FFNS 110mcg, -1.86; p50.007). Treatment differences for the three individual eye symptoms were also significant for FFNS (p0.044). CONCLUSIONS: Once-daily FFNS 110mcg demonstrated clinically significant, sustained 24-hour efficacy for the ocular symptoms associated with ragweed-induced seasonal allergic rhinitis. Funding: GlaxoSmithKline
907
Fluticasone Furoate* (FF) Nasal Spray-Development of a Next-Generation Delivery System for Allergic Rhinitis [*USAN approved name] W. Berger1, J. W. Godfrey2, A. C. Grant2, A. L. Slater2, S. J. Broughton2; 1 Southern California Research, Mission Viejo, CA, 2GlaxoSmithKline Research & Development, Ware, Hertfordshire, UNITED KINGDOM. RATIONALE: Market research with patients and clinicians identified several features of existing nasal sprays which make them difficult and unpleasant to use. METHODS: Engineering and design solutions were developed for the FF delivery system to improve patient experience. RESULTS: d Consistent dose A trigger mechanism was developed to minimise the potential variation in dose administration. d
The device remains ready to use
The lid was designed to assure that the device remains primed after first use. d Easier third party administration The unique, side-actuated design minimises movement of the nozzle within the nose during actuation and eliminates the need for care-giver’s fingers to be close to the patient’s nose. d
Patient comfort
A shorter nozzle is possible due to the side-actuated design. A low dose volume (50ml) is delivered as a fine mist to minimise the amount of
formulation available to run down the back of the throat or drip from the nostrils. d
Easily carried
The sturdy, plastic device provides additional protection to the inner container. Engineering features prevent accidental actuation when the lid is in place. In-vitro tests have confirmed that the device is robust and delivers a consistent dose, even when left unused for a period of 6 weeks. Patient comfort was evaluated in a Phase III clinical study (n5302) where 97% of patients found the drug product comfortable to use and 95% considered the product easy to carry. CONCLUSIONS: The novel delivery system developed for FF Nasal Spray addresses several shortcomings identified by patients and clinicians in existing products. Funding: GlaxoSmithKline
908
Once-daily Fluticasone Furoate* Nasal Spray (FF) Effectively Treats Ocular Symptoms Of Seasonal Allergic Rhinitis (SAR) Caused By Mountain Cedar Pollen *USAN Approved Name P. Ratner1, C. Andrews2, J. van Bavel3, T. Toler4, A. Ellsworth4, E. Philpot4; 1Sylvana Research Associates, San Antonio, TX, 2Diagnostics Research Group, San Antonio, TX, 3Allergy and Asthma Associates, Austin, TX, 4GlaxoSmithKline, Research Triangle Park, NC. RATIONALE: FF, a novel enhanced-affinity steroid, was evaluated for relief of both ocular and nasal SAR symptoms. METHODS: 302 subjects (12 years) allergic to mountain cedar pollen were randomized to once-daily FF 110mcg or placebo spray. Ocular endpoints included mean change from baseline (MCFB) over the entire 2week treatment period in daily reflective total ocular symptoms scores (rTOSS), and MCFB in morning pre-dose instantaneous total ocular symptoms scores (iTOSS). Total ocular scores were the sum of 3 symptoms: eye itching/burning; tearing/watering; and redness. The MCFB in daily reflective total nasal symptoms scores (rTNSS) was the primary endpoint. Data were analyzed using ANCOVA. RESULTS: FF 110mcg was significantly more effective than placebo for the MCFB in the rTOSS (p50.008) and the MCFB in morning pre-dose iTOSS (p50.009), indicating 24-hour ocular symptom efficacy. FF 110mcg also was significantly more effective on the MCFB in rTNSS (p50.003). No serious AEs were reported, and epistaxis, the most common drug-related AE, occurred in 7% and 5% of placebo and FF subjects, respectively, but only 3% of those in each group were considered drugrelated. CONCLUSIONS: This study demonstrated that, in addition to nasal symptom relief, once-daily FF 110 mcg showed efficacy for ocular symptoms in subjects with SAR. Although the mechanism of action remains to be determined, the efficacy of FF on ocular symptoms may involve modulation of allergen-induced increases in nasal neuronal activity leading to decreased symptoms. Funding: GlaxoSmithKline
MONDAY
906