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Topical Intranasal Hexabrix Is Effective In Reducing the Acute Response to Nasal Challenge with Allergen (NAC)
AB200 Abstracts
767
BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR) J. van Bavel1, F. C. Hampel2, P. H. Ratner3, A. Melchior4, S. A. Dunbar4, S. K. Tantry4, P. M. Dorinsky4; 1Allergy and Asthma Associates, Austin, TX, 2Central Texas Allergy and Asthma, New Braunfels, TX, 3Sylvana Research Associates, San Antonio, TX, 4Teva Branded Pharmaceutical Products R&D, Inc., Horsham, PA. RATIONALE: Symptoms associated with SAR are troublesome and contribute to impaired QOL. While intranasal corticosteroids provide relief from most nasal symptoms, they are currently only available as aqueous formulations. This study evaluated the effect of an aerosol formulation of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) on nasal symptom relief and QOL in subjects with SAR. METHODS: Subjects enrolled in this 2-week, phase 3, multicenter, double-blind, placebo-controlled, parallel-group study were randomized to receive either placebo (n5171) or BDP HFA 320 mg/d (n5167). While the primary efficacy measure was subject-reported nasal symptoms, physicians also assessed symptom relief using the Physician-Assessed Total Nasal Symptom Score (PNSS). Additionally, adult subjects self-assessed their QOL by completing the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Treatment with BDP HFA resulted in a greater reduction from baseline in the average PNSS compared with placebo (-0.97 [95% CI: -1.5, -0.4]; P<0.001). Additionally, greater improvements were also seen for each of the individual physician-assessed nasal symptoms with BDP HFA compared to placebo. Similarly, treatment with BDP HFA 320 mg/d resulted in significant improvement in QOL compared with placebo (-0.48; 95% CI: -0.8, -0.1; P50.005). Moreover, for most of the domains of the RQLQ, improvements from baseline were greater with BDP HFA than with placebo. CONCLUSIONS: This study demonstrated that BDP HFA nasal aerosol provides both substantial nasal symptom relief and significant QOL improvements in subjects with SAR. Thus, BDP HFA nasal aerosol should provide a new and effective alternative SAR treatment.
MONDAY
768
Topical Intranasal Hexabrix Is Effective In Reducing the Acute Response to Nasal Challenge with Allergen (NAC) F. M. Baroody1, S. Vishwanath1, M. Chaaban1, M. deTineo1, K. H. Lasser2, E. Lasser3, R. M. Naclerio1; 1University of Chicago, Chicago, IL, 2Kaiser Permanente, San Diego, CA, 3University of California San Diego, San Diego, CA. RATIONALE: Hexabrix is a currently available intravenous contrast media. In vitro and animal studies suggest that it reduces IgE mediated histamine release from mast cells. We tested the efficacy of Hexabrix on the acute response to NAC. METHODS: We performed a randomized, placebo-controlled, doubleblind, cross-over study to examine the effect of Hexabrix on subjects with asymptomatic seasonal allergic rhinitis. After a nasal peak inspiratory flow (NPIF) measurement, subjects were treated with 200 mcl of Hexabrix or saline, placed on the left nasal septum. Twenty minutes later, baseline symptoms and NPIF were recorded, and the subjects underwent a challenge with the diluent for the antigen extracts followed by 2 increasing doses of grass or ragweed allergen separated by 20 minutes. The allergens were applied via filter paper discs. Fifteen minutes after each challenge, subjects recorded sneezes and symptoms of runny, stuffy and itchy nose/throat/eyes on a scale from 0-3. NPIF was measured after the recording of symptoms. RESULTS: Topical treatment with Hexabrix was well tolerated. When the total change from diluent challenge was compared between active and placebo treatments, Hexabrix resulted in a significant reduction in sneezes (p50.018) and runny nose symptoms (p50.048) and reduced stuffy nose and itching symptoms though not significantly. The reduction in airflow after challenge was less after treatment with Hexabrix, but this effect did not reach statistical significance. CONCLUSIONS: Topical treatment with Hexabrix reduced the acute NAC response suggesting an effect on mast cells. This agent could provide a novel effective intervention for the treatment of subjects with allergic rhinitis.
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
769
Intranasal Corticosteroid Theraphy in Idiopathic Rhinitis: a Comparative Study with Allergic Rhinitis A. Baccioglu Kavut, F. Kalpaklioglu; Kirikkale University Faculty of Medicine, Department of Allergic Diseases, Kirikkale, TURKEY. RATIONALE: Intranasal corticosteroids are considered to be highly effective in allergic rhinitis (AR). However, their efficacy in idiopathic rhinitis (IR) is controversial, as its’ unknown underlying pathophysiology. Objective: to evaluate the efficacy of triamcinolone-acetonide nasal spray (TANS) in IR patients in comparison with AR. METHODS: Patients with perennial rhinitis were classified as AR:16 if skin prick tests (SPT)s were positive to house-dust-mite, and IR:25 with negative SPTs and exclusion of other nasal diseases. TANS was prescribed 110mcg/day: screening with nasal symptom scores (NSS), nasal peak-inspiratory-flow rate (nPIFR), health-related quality of life (HRQoL) questionnaires (generic:SF-36 and rhinitis specific:MiniRQLQ) at baseline, after 2 and 6 weeks of treatment. RESULTS: The improvement rates of NSS were 56% (IR) and 75% (AR). Therapeutic response of IR was earlier and greater than AR, whereas AR had a late statistical improvement in NSS. Symptoms which had the highest benefit from TANS were rhinorrea and nasal obstruction in IR while rhinorrea, nasal itching and postnasal drenage in AR. The improvement of nasal obstruction and nPIFR were statistically significant in IR in contrast with AR. TANS was well tolerated in both rhinitis types. The most frequently reported adverse events were headache and bitter taste. IR had similar improvement in some MiniRQLQ scores as AR despite no significant increase in SF-36. CONCLUSION: TANS is a safe and effective treatment for IR patients as AR by means of subjective and objective parameters in addition to HRQoL. The effectiveness of anti-inflammatory treatment may indicate that IR is an inflammatory disease.
770
Results of the Rhinoconjunctivitis Related Quality of Life Questionnaire Administered to Subjects with Seasonal Allergic Rhinitis Following Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol C. Andrews1, P. Ratner2, B. Martin2, W. Howland3, H. Huang4, S. Y. Desai4, F. Bode4; 1Diagnostics Research Group, San Antonio, TX, 2Sylvana Research Associates, San Antonio, TX, 3Southwest Allergy and Asthma Center, San Antonio, TX, 4Sepracor Inc, Marlborough, MA. RATIONALE: Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a treatment for allergic rhinitis. Improvement in the rhinoconjunctivitis related quality of life associated with seasonal allergic rhinitis (SAR) was measured by the rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]) in _12 years of age randomized to CIC-HFA or placebo. subjects > METHODS: Data was collected as part of a placebo-controlled, doubleblind, parallel group, multicenter study during the Texas Mountain Cedar pollen season in subjects randomized to CIC-HFA 80mg (N5226), CIC-HFA 160mg (N5225), or placebo (N5220) once-daily in the morning for 2 weeks. Change in RQLQ[S] scores was recorded for the intent-to_3.0 treat population and calculated in subjects with baseline RQLQ[S] > (CIC-HFA 80mg:N5187, CIC-HFA 160mg:N5183, placebo:N5183). The RQLQ[S] was self-administered by subjects prior to randomization and at the end of the double-blind study medication period. Change from baseline in overall RQLQ[S], a key secondary endpoint, and in the individual domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, emotional, and eye symptoms over the 2-week treatment period were evaluated. RESULTS: CIC-HFA 80mg (P<0.0124) demonstrated statistically significant improvements and CIC-HFA 160mg demonstrated numerical improvements in overall RQLQ[S] (P-value not determined) and CIC-HFA 80mg and CIC-HFA 160mg demonstrated numerical improvements in individual domains of RQLQ[S] (P<0.05 for all, unadjusted for multiplicity) compared to placebo over the 2-week treatment period. CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 80mg or CIC-HFA 160mg demonstrated improvements in the rhinoconjunctivitis related quality of life in subjects with SAR to Mountain Cedar pollen.
767
BDP HFA Nasal Aerosol Effectively Improves Nasal Symptom Relief and Health-Related Quality of Life (QOL) in Subjects with Seasonal Allergic Rhinitis (SAR) J. van Bavel1, F. C. Hampel2, P. H. Ratner3, A. Melchior4, S. A. Dunbar4, S. K. Tantry4, P. M. Dorinsky4; 1Allergy and Asthma Associates, Austin, TX, 2Central Texas Allergy and Asthma, New Braunfels, TX, 3Sylvana Research Associates, San Antonio, TX, 4Teva Branded Pharmaceutical Products R&D, Inc., Horsham, PA. RATIONALE: Symptoms associated with SAR are troublesome and contribute to impaired QOL. While intranasal corticosteroids provide relief from most nasal symptoms, they are currently only available as aqueous formulations. This study evaluated the effect of an aerosol formulation of beclomethasone dipropionate hydrofluoroalkane (BDP HFA) on nasal symptom relief and QOL in subjects with SAR. METHODS: Subjects enrolled in this 2-week, phase 3, multicenter, double-blind, placebo-controlled, parallel-group study were randomized to receive either placebo (n5171) or BDP HFA 320 mg/d (n5167). While the primary efficacy measure was subject-reported nasal symptoms, physicians also assessed symptom relief using the Physician-Assessed Total Nasal Symptom Score (PNSS). Additionally, adult subjects self-assessed their QOL by completing the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ). RESULTS: Treatment with BDP HFA resulted in a greater reduction from baseline in the average PNSS compared with placebo (-0.97 [95% CI: -1.5, -0.4]; P<0.001). Additionally, greater improvements were also seen for each of the individual physician-assessed nasal symptoms with BDP HFA compared to placebo. Similarly, treatment with BDP HFA 320 mg/d resulted in significant improvement in QOL compared with placebo (-0.48; 95% CI: -0.8, -0.1; P50.005). Moreover, for most of the domains of the RQLQ, improvements from baseline were greater with BDP HFA than with placebo. CONCLUSIONS: This study demonstrated that BDP HFA nasal aerosol provides both substantial nasal symptom relief and significant QOL improvements in subjects with SAR. Thus, BDP HFA nasal aerosol should provide a new and effective alternative SAR treatment.
MONDAY
768
Topical Intranasal Hexabrix Is Effective In Reducing the Acute Response to Nasal Challenge with Allergen (NAC) F. M. Baroody1, S. Vishwanath1, M. Chaaban1, M. deTineo1, K. H. Lasser2, E. Lasser3, R. M. Naclerio1; 1University of Chicago, Chicago, IL, 2Kaiser Permanente, San Diego, CA, 3University of California San Diego, San Diego, CA. RATIONALE: Hexabrix is a currently available intravenous contrast media. In vitro and animal studies suggest that it reduces IgE mediated histamine release from mast cells. We tested the efficacy of Hexabrix on the acute response to NAC. METHODS: We performed a randomized, placebo-controlled, doubleblind, cross-over study to examine the effect of Hexabrix on subjects with asymptomatic seasonal allergic rhinitis. After a nasal peak inspiratory flow (NPIF) measurement, subjects were treated with 200 mcl of Hexabrix or saline, placed on the left nasal septum. Twenty minutes later, baseline symptoms and NPIF were recorded, and the subjects underwent a challenge with the diluent for the antigen extracts followed by 2 increasing doses of grass or ragweed allergen separated by 20 minutes. The allergens were applied via filter paper discs. Fifteen minutes after each challenge, subjects recorded sneezes and symptoms of runny, stuffy and itchy nose/throat/eyes on a scale from 0-3. NPIF was measured after the recording of symptoms. RESULTS: Topical treatment with Hexabrix was well tolerated. When the total change from diluent challenge was compared between active and placebo treatments, Hexabrix resulted in a significant reduction in sneezes (p50.018) and runny nose symptoms (p50.048) and reduced stuffy nose and itching symptoms though not significantly. The reduction in airflow after challenge was less after treatment with Hexabrix, but this effect did not reach statistical significance. CONCLUSIONS: Topical treatment with Hexabrix reduced the acute NAC response suggesting an effect on mast cells. This agent could provide a novel effective intervention for the treatment of subjects with allergic rhinitis.
J ALLERGY CLIN IMMUNOL FEBRUARY 2011
769
Intranasal Corticosteroid Theraphy in Idiopathic Rhinitis: a Comparative Study with Allergic Rhinitis A. Baccioglu Kavut, F. Kalpaklioglu; Kirikkale University Faculty of Medicine, Department of Allergic Diseases, Kirikkale, TURKEY. RATIONALE: Intranasal corticosteroids are considered to be highly effective in allergic rhinitis (AR). However, their efficacy in idiopathic rhinitis (IR) is controversial, as its’ unknown underlying pathophysiology. Objective: to evaluate the efficacy of triamcinolone-acetonide nasal spray (TANS) in IR patients in comparison with AR. METHODS: Patients with perennial rhinitis were classified as AR:16 if skin prick tests (SPT)s were positive to house-dust-mite, and IR:25 with negative SPTs and exclusion of other nasal diseases. TANS was prescribed 110mcg/day: screening with nasal symptom scores (NSS), nasal peak-inspiratory-flow rate (nPIFR), health-related quality of life (HRQoL) questionnaires (generic:SF-36 and rhinitis specific:MiniRQLQ) at baseline, after 2 and 6 weeks of treatment. RESULTS: The improvement rates of NSS were 56% (IR) and 75% (AR). Therapeutic response of IR was earlier and greater than AR, whereas AR had a late statistical improvement in NSS. Symptoms which had the highest benefit from TANS were rhinorrea and nasal obstruction in IR while rhinorrea, nasal itching and postnasal drenage in AR. The improvement of nasal obstruction and nPIFR were statistically significant in IR in contrast with AR. TANS was well tolerated in both rhinitis types. The most frequently reported adverse events were headache and bitter taste. IR had similar improvement in some MiniRQLQ scores as AR despite no significant increase in SF-36. CONCLUSION: TANS is a safe and effective treatment for IR patients as AR by means of subjective and objective parameters in addition to HRQoL. The effectiveness of anti-inflammatory treatment may indicate that IR is an inflammatory disease.
770
Results of the Rhinoconjunctivitis Related Quality of Life Questionnaire Administered to Subjects with Seasonal Allergic Rhinitis Following Treatment with Ciclesonide Hydrofluoroalkane Nasal Aerosol C. Andrews1, P. Ratner2, B. Martin2, W. Howland3, H. Huang4, S. Y. Desai4, F. Bode4; 1Diagnostics Research Group, San Antonio, TX, 2Sylvana Research Associates, San Antonio, TX, 3Southwest Allergy and Asthma Center, San Antonio, TX, 4Sepracor Inc, Marlborough, MA. RATIONALE: Ciclesonide hydrofluoroalkane nasal aerosol (CIC-HFA) is currently in development as a treatment for allergic rhinitis. Improvement in the rhinoconjunctivitis related quality of life associated with seasonal allergic rhinitis (SAR) was measured by the rhinoconjunctivitis quality of life questionnaire with standardized activities (RQLQ[S]) in _12 years of age randomized to CIC-HFA or placebo. subjects > METHODS: Data was collected as part of a placebo-controlled, doubleblind, parallel group, multicenter study during the Texas Mountain Cedar pollen season in subjects randomized to CIC-HFA 80mg (N5226), CIC-HFA 160mg (N5225), or placebo (N5220) once-daily in the morning for 2 weeks. Change in RQLQ[S] scores was recorded for the intent-to_3.0 treat population and calculated in subjects with baseline RQLQ[S] > (CIC-HFA 80mg:N5187, CIC-HFA 160mg:N5183, placebo:N5183). The RQLQ[S] was self-administered by subjects prior to randomization and at the end of the double-blind study medication period. Change from baseline in overall RQLQ[S], a key secondary endpoint, and in the individual domains of activities, sleep, non-nose/eye symptoms, practical problems, nasal symptoms, emotional, and eye symptoms over the 2-week treatment period were evaluated. RESULTS: CIC-HFA 80mg (P<0.0124) demonstrated statistically significant improvements and CIC-HFA 160mg demonstrated numerical improvements in overall RQLQ[S] (P-value not determined) and CIC-HFA 80mg and CIC-HFA 160mg demonstrated numerical improvements in individual domains of RQLQ[S] (P<0.05 for all, unadjusted for multiplicity) compared to placebo over the 2-week treatment period. CONCLUSIONS: In this study, once-daily treatment with CIC-HFA 80mg or CIC-HFA 160mg demonstrated improvements in the rhinoconjunctivitis related quality of life in subjects with SAR to Mountain Cedar pollen.