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Ectoin®, a Novel, Non-Drug, Extremophile-Based Device, Relieves Allergic Rhinoconjunctivitis Symptoms in Patients in an Environmental Exposure Chamber Model
AB202 Abstracts
775
Regular Use of Cetirizine Demonstrates Consistent Relief from Symptoms of Seasonal Allergic Rhinitis in Children E. R. Urdaneta1, P. A. Przygoda1, C. L. Lin1, M. K. Patel1, K. B. Franklin1, M. Wu2; 1McNeil Consumer Healthcare, Fort Washington, PA, 2 Johnson & Johnson Consumer Products Worldwide, Morris Plains, NJ. RATIONALE: Many children with seasonal allergic rhinitis (SAR) require regular use of antihistamines to manage symptoms. To evaluate whether cetirizine provides continued symptomatic relief throughout treatment in children with SAR, efficacy was evaluated in each week of three 2week studies. METHODS: In three 2-week studies, healthy children aged 2-11 years experiencing SAR symptoms were randomized to daily doses of cetirizine 5 or 10mg, loratadine 10mg, or placebo. Total Symptom Severity Complex (TSSC) score was the sum of subject’s 4-5 individual severity scores. Change and percent reduction from baseline TSSC were calculated daily for the first week; corresponding means were calculated weekly. RESULTS: Efficacy was evaluated for the intention-to-treat population, including children administered cetirizine 5mg (N564), cetirizine 10mg (N5301), loratadine 10mg (N5219), and placebo (N5367). Daily symptom scores for cetirizine-treated children throughout the first week demonstrate that, in all three studies, reductions in TSSC compared to baseline were greater than those attained on the first treatment day. Weekly symptom scores demonstrate that, in all three studies, reductions in TSSC compared to baseline were maintained for each cetirizine-treated week, except in one small group (N511) stratified by weight to cetirizine 5mg in one study. Percent reductions from baseline TSSC were >35% after 1 and 2 weeks of cetirizine 5mg treatment. Percent reductions from baseline TSSC were >20% after 1 week and >30% after 2 weeks of cetirizine 10mg treatment. CONCLUSIONS: In children aged 2-11 years, 5- or 10-mg daily doses of cetirizine improved SAR symptoms and maintained consistent relief throughout 2 treatment weeks. EctoinÒ, a Novel, Non-Drug, Extremophile-Based Device, Relieves Allergic Rhinoconjunctivitis Symptoms in Patients in an Environmental Exposure Chamber Model A. Salapatek1, M. Bates1, A. Bilstein2, D. Patel1; 1Cetero Research, Mississauga, ON, CANADA, 2bitop AG, Stockumer, GERMANY. RATIONALE: Despite the many pharmaceutical treatments available, allergy patients remain dissatisfied due to deleterious side-effects and ineffective symptom relief. A new, naturally-sourced, extremophile derived, anti-allergic device, EctoinÒ, was investigated in this study. The objective was to assess the relative efficacy of EctoinÒ Nasal Spray and Eye Drops compared to placebo on the complex of rhinoconjuntivitis symptoms in subjects exposed to highly controlled ragweed levels in an Environmental Exposure Chamber. METHODS: This was a randomized, double-blind, placebo-controlled, crossover study. After a qualifying exposure visit, subjects were randomized to active or placebo nasal spray and eye drops for 13 days of at-home dosing followed by a post-treatment ragweed exposure. Primary endpoints included Total Nasal Symptom Scores and Total Ocular Symptom Scores. Single symptoms were also analyzed. Changes from baseline were compared using an analysis of covariance. RESULTS: EctoinÒ provided greater relief from nasal, ocular and non-nasal symptoms compared to placebo. EctoinÒ treated subjects experienced a reduction of 19.68%, 24.44%, and 25.03% for overall nasal, ocular and non-nasal symptoms, respectively. Decreases in baseline adjusted mean area under the curve values were larger for EctoinÒ for every endpoint in the study with most being statistically significant. EctoinÒ was easily tolerated with little-to-no side-effects. CONCLUSIONS: EctoinÒ effectively relives all of the hallmark symptoms of rhinoconjuntivitis as evidenced in this highly controlled, robust clinical study. Treatment effects were similar to those of the currently available drug product classes such as antihistamines, steroids and leukotriene modifiers, but with virtually no side effects at all.
776
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
777
Management of Allergic Rhinitis patients with Nasal Steroids and NeilMedÒ Sinus Rinseä System with Isotonic Saline: A Prospective Pilot Study S. A. Nguyen, J. Condrey, R. J. Schlosser; Medical University of South Carolina, charleston, SC. RATIONALE: To determine if the addition of large volume, low positive pressure nasal irrigations delivered with the NeilMedÒ Sinus Rinseä System with isotonic sodium chloride (hereinafter "saline") added to intranasal corticossteroid therapy improves quality of life and objective measures of nasal breathing in patients with allergic rhinitis when compared to intranasal corticossteroid alone. METHODS: A prospective, unblinded pilot study of patients with allergic rhinitis already on intranasal corticosteroid pharmacotherapy. Patients added large-volume low-pressure saline irrigation with the NeilMedÒ Sinus Rinseä System twice daily for 8 weeks to their ongoing regimine of nasal corticosteroid. Mini respiratory quality of life questionnaire (mRQLQ) assessment and Nasal Peak Inspiratory Flow (NPIF) were performed at baseline, 4 weeks, and 8 weeks. RESULTS: A total of 17 patients were enrolled. Twice-daily use of the NeilMedÒ Sinus Rinseä System with saline significantly (p<0.001) reduced mRQLQ scores, from 37.765.2 (baseline) to 14.362.8 (4 weeks) to 9.0562.7 (8 weeks). No significant changes were seen in NPIF, pattern use of nasal steroid or adverse events. CONCLUSIONS: Large volume, low positive pressure nasal irrigation performed with the NeilMedÒ Sinus Rinseä System is an effective adjunctive therapy to improve quality of life in patients with allergic rhinitis already on intranasal corticosteroid therapy. Trial Registration: clinicaltrials.gov Identifier: NCT01030146
778
MONDAY
Cellulose Powder for the Treatment of Persistent Allergic Rhinitis in Children and Adolescents: a Pilot Study G. F. Wandalsen, A. I. Mendes, D. Sole; Federal University of S~ao Paulo, S~ao Paulo - SP, BRAZIL. RATIONALE: Cellulose powder has been used for the treatment of allergic rhinitis for several years in different countries. It may act as an artificial barrier to reduce exposition to allergens and irritants. METHODS: Eight patients (8 to 16 years) with persistent allergic rhinitis, without nasal or systemic steroids for at least one month were treated with a cellulose powder (Nasaleze, one application per nostril twice daily) for two weeks. Nasal symptoms score (range 0 to 12), nasal congestion (acoustic rhinometry) and nonspecific nasal hyperreactivity (histamine nasal provocation test) were measured before and after treatment. RESULTS: Median nasal symptoms score was significantly lower at the end of treatment (8.5 vs. 4.5; p50.04) and symptoms reduction was observed in all patients with only one exception. No significant difference was noted in nasal volume (first 5cm [V5]: 8.6cm3 vs. 9.2cm3; p50.18), but median concentration of histamine necessary to induce 20% decrease in nasal volume (V5) was significantly higher after treatment (0.375mg/ ml vs. 2.0mg/ml; p50.04). No adverse event was reported. CONCLUSIONS: This preliminary study indicates that cellulose powder can be useful in the treatment of patients with allergic rhinitis. Further evaluations are still necessary to define its efficacy and role in the treatment of allergic rhinitis.
775
Regular Use of Cetirizine Demonstrates Consistent Relief from Symptoms of Seasonal Allergic Rhinitis in Children E. R. Urdaneta1, P. A. Przygoda1, C. L. Lin1, M. K. Patel1, K. B. Franklin1, M. Wu2; 1McNeil Consumer Healthcare, Fort Washington, PA, 2 Johnson & Johnson Consumer Products Worldwide, Morris Plains, NJ. RATIONALE: Many children with seasonal allergic rhinitis (SAR) require regular use of antihistamines to manage symptoms. To evaluate whether cetirizine provides continued symptomatic relief throughout treatment in children with SAR, efficacy was evaluated in each week of three 2week studies. METHODS: In three 2-week studies, healthy children aged 2-11 years experiencing SAR symptoms were randomized to daily doses of cetirizine 5 or 10mg, loratadine 10mg, or placebo. Total Symptom Severity Complex (TSSC) score was the sum of subject’s 4-5 individual severity scores. Change and percent reduction from baseline TSSC were calculated daily for the first week; corresponding means were calculated weekly. RESULTS: Efficacy was evaluated for the intention-to-treat population, including children administered cetirizine 5mg (N564), cetirizine 10mg (N5301), loratadine 10mg (N5219), and placebo (N5367). Daily symptom scores for cetirizine-treated children throughout the first week demonstrate that, in all three studies, reductions in TSSC compared to baseline were greater than those attained on the first treatment day. Weekly symptom scores demonstrate that, in all three studies, reductions in TSSC compared to baseline were maintained for each cetirizine-treated week, except in one small group (N511) stratified by weight to cetirizine 5mg in one study. Percent reductions from baseline TSSC were >35% after 1 and 2 weeks of cetirizine 5mg treatment. Percent reductions from baseline TSSC were >20% after 1 week and >30% after 2 weeks of cetirizine 10mg treatment. CONCLUSIONS: In children aged 2-11 years, 5- or 10-mg daily doses of cetirizine improved SAR symptoms and maintained consistent relief throughout 2 treatment weeks. EctoinÒ, a Novel, Non-Drug, Extremophile-Based Device, Relieves Allergic Rhinoconjunctivitis Symptoms in Patients in an Environmental Exposure Chamber Model A. Salapatek1, M. Bates1, A. Bilstein2, D. Patel1; 1Cetero Research, Mississauga, ON, CANADA, 2bitop AG, Stockumer, GERMANY. RATIONALE: Despite the many pharmaceutical treatments available, allergy patients remain dissatisfied due to deleterious side-effects and ineffective symptom relief. A new, naturally-sourced, extremophile derived, anti-allergic device, EctoinÒ, was investigated in this study. The objective was to assess the relative efficacy of EctoinÒ Nasal Spray and Eye Drops compared to placebo on the complex of rhinoconjuntivitis symptoms in subjects exposed to highly controlled ragweed levels in an Environmental Exposure Chamber. METHODS: This was a randomized, double-blind, placebo-controlled, crossover study. After a qualifying exposure visit, subjects were randomized to active or placebo nasal spray and eye drops for 13 days of at-home dosing followed by a post-treatment ragweed exposure. Primary endpoints included Total Nasal Symptom Scores and Total Ocular Symptom Scores. Single symptoms were also analyzed. Changes from baseline were compared using an analysis of covariance. RESULTS: EctoinÒ provided greater relief from nasal, ocular and non-nasal symptoms compared to placebo. EctoinÒ treated subjects experienced a reduction of 19.68%, 24.44%, and 25.03% for overall nasal, ocular and non-nasal symptoms, respectively. Decreases in baseline adjusted mean area under the curve values were larger for EctoinÒ for every endpoint in the study with most being statistically significant. EctoinÒ was easily tolerated with little-to-no side-effects. CONCLUSIONS: EctoinÒ effectively relives all of the hallmark symptoms of rhinoconjuntivitis as evidenced in this highly controlled, robust clinical study. Treatment effects were similar to those of the currently available drug product classes such as antihistamines, steroids and leukotriene modifiers, but with virtually no side effects at all.
776
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
777
Management of Allergic Rhinitis patients with Nasal Steroids and NeilMedÒ Sinus Rinseä System with Isotonic Saline: A Prospective Pilot Study S. A. Nguyen, J. Condrey, R. J. Schlosser; Medical University of South Carolina, charleston, SC. RATIONALE: To determine if the addition of large volume, low positive pressure nasal irrigations delivered with the NeilMedÒ Sinus Rinseä System with isotonic sodium chloride (hereinafter "saline") added to intranasal corticossteroid therapy improves quality of life and objective measures of nasal breathing in patients with allergic rhinitis when compared to intranasal corticossteroid alone. METHODS: A prospective, unblinded pilot study of patients with allergic rhinitis already on intranasal corticosteroid pharmacotherapy. Patients added large-volume low-pressure saline irrigation with the NeilMedÒ Sinus Rinseä System twice daily for 8 weeks to their ongoing regimine of nasal corticosteroid. Mini respiratory quality of life questionnaire (mRQLQ) assessment and Nasal Peak Inspiratory Flow (NPIF) were performed at baseline, 4 weeks, and 8 weeks. RESULTS: A total of 17 patients were enrolled. Twice-daily use of the NeilMedÒ Sinus Rinseä System with saline significantly (p<0.001) reduced mRQLQ scores, from 37.765.2 (baseline) to 14.362.8 (4 weeks) to 9.0562.7 (8 weeks). No significant changes were seen in NPIF, pattern use of nasal steroid or adverse events. CONCLUSIONS: Large volume, low positive pressure nasal irrigation performed with the NeilMedÒ Sinus Rinseä System is an effective adjunctive therapy to improve quality of life in patients with allergic rhinitis already on intranasal corticosteroid therapy. Trial Registration: clinicaltrials.gov Identifier: NCT01030146
778
MONDAY
Cellulose Powder for the Treatment of Persistent Allergic Rhinitis in Children and Adolescents: a Pilot Study G. F. Wandalsen, A. I. Mendes, D. Sole; Federal University of S~ao Paulo, S~ao Paulo - SP, BRAZIL. RATIONALE: Cellulose powder has been used for the treatment of allergic rhinitis for several years in different countries. It may act as an artificial barrier to reduce exposition to allergens and irritants. METHODS: Eight patients (8 to 16 years) with persistent allergic rhinitis, without nasal or systemic steroids for at least one month were treated with a cellulose powder (Nasaleze, one application per nostril twice daily) for two weeks. Nasal symptoms score (range 0 to 12), nasal congestion (acoustic rhinometry) and nonspecific nasal hyperreactivity (histamine nasal provocation test) were measured before and after treatment. RESULTS: Median nasal symptoms score was significantly lower at the end of treatment (8.5 vs. 4.5; p50.04) and symptoms reduction was observed in all patients with only one exception. No significant difference was noted in nasal volume (first 5cm [V5]: 8.6cm3 vs. 9.2cm3; p50.18), but median concentration of histamine necessary to induce 20% decrease in nasal volume (V5) was significantly higher after treatment (0.375mg/ ml vs. 2.0mg/ml; p50.04). No adverse event was reported. CONCLUSIONS: This preliminary study indicates that cellulose powder can be useful in the treatment of patients with allergic rhinitis. Further evaluations are still necessary to define its efficacy and role in the treatment of allergic rhinitis.