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P324 Efficacy of MP-AzeFlu in children with seasonal allergic rhinitis: importance of child symptom assessment
S118
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 117 (2016) S22eS124
P324 EFFICACY OF MP-AZEFLU IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS: IMPORTANCE OF CHILD SYMPTOM ASSESSMENT E. Sher*1, S. Gawchik2, S. Fineman3, W. Berger4, 1. Ocean, NJ; 2. Chester, PA; 3. Marietta, GA; 4. Mission Viejo, CA. Introduction: The primary objective of this study was to assess the efficacy of MP-AzeFlu for the treatment of children with SAR based on patient self-reporting of nasal and ocular symptoms. Methods: A total of 348 children 4 to 11 years with moderate-tosevere SAR were randomized to treatment with MP-AzeFlu (Meda) or placebo nasal sprays 1 spray/nostril bid (daily dose MP-AzeFlu group: AZE 548 mg; FP: 200 mg) in a randomized, placebo-controlled, parallel group, 14-day, double-blind trial. Efficacy endpoints were overall change from baseline in reflective total nasal symptom score (rTNSS, AM + PM), reflective total ocular symptom score (rTOSS), and in individual nasal and ocular symptom scores in children 6 to11 years (n¼304) recorded twice daily in eDiaries. These were analyzed post hoc by the degree of child self-rating compared to caregiver rating. Change in quality of life (QoL) was assessed by the pediatric quality of life questionnaire (PRQLQ). Results: MP-AzeFlu-treated children experienced a statistically superior (Diff -0.29; 95% CI -0.55, -0.04; p¼0.027) and clinically relevant improvement in QoL compared to placebo-treated children. As the extent of child self-rating increased compared to caregiver rating, so did the treatment difference between MP-AzeFlu and placebo. In the group which comprised >90% child self-rating (n¼82), MP-AzeFlu resulted in significantly better relief than placebo for nasal symptoms (p¼0.002), ocular symptoms (p¼0.009), and each individual nasal and ocular symptom assessed (p0.0355) (except rhinorrhea p¼0.064). Conclusion: MP-AzeFlu is an effective treatment for AR in children. A simple and child-specific tool to assess efficacy in pediatric AR trials is urgently needed.
P325 TIME TO A CLINICALLY-MEANINGFUL RESPONSE WITH MP-AZEFLU IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS (SAR) T. Mahr1, E. Sher2, S. Gawchik3, S. Fineman4, W. Berger5, 1. La Crosse, WI; 2. Ocean, NJ; 3. Chester, PA; 4. Marietta, GA; 5. Mission Viejo, CA. Introduction: The efficacy of MP-AzeFlu was evaluated in children with moderate-to-severe SAR in a 2-week randomized, controlled trial. This analysis compared the proportion of children achieving ¼50% reduction in nasal symptoms and time taken to achieve that reduction following treatment with MP-AzeFlu or placebo (PLA). The importance of the child efficacy assessment is also addressed. Methods: 304 children 6 to 11 years of age were randomized into 14-day, double-blind trial of MP-AzeFlu (Meda) or PLA 1 spray/ nostril bid (daily dose MP-AzeFlu: AZE 548 mg; FP: 200 mg). Children or their caregivers recorded nasal symptom scores in an eDiary twice daily. Change from baseline in AM + PM rTNSS of 50% was the defined response and was assessed by degree of child self-rating. Time to response was analyzed by Kaplan-Meier estimates and log-rank tests post hoc. Quality of life (QoL) was assessed by the pediatric rhinoconjunctivitis quality of life questionnaire (PRQLQ). Results: MP-AzeFlu-treated children experienced a statistically superior (Diff -0.29; 95% CI -0.55, -0.04; p¼0.027) and clinicallyrelevant improvement in QoL compared to PLA-treated children. eDiary ratings demonstrated greater effect between MP-AzeFlu and PLA in children rating their own nasal symptoms for >90% of the time (n¼82). In this group, 38.9% of MP-AzeFlu children achieved response up to 10 days faster than PLA (10.9%; p¼0.0065).
Conclusion: MP-AzeFlu provided more complete and faster relief than PLA in children with AR. Efficacy in AR should be assessed in clinically-relevant ways but symptom severity should also be monitored using validated and reliable methods that children are capable of assessing themselves.
P326 A PHASE 2 CONSUMER EXPERIENCE STUDY OF A CARBON DIOXIDE NASAL SPRAY IN CONGESTED SUBJECTS S. Johnson*, A. Hamilton, R. Karwal, L. Lauersen, Parsippany, NJ. Introduction: Earlier clinical studies of allergic rhinitis have shown that relief of associated nasal symptoms is possible with nasally administered CO2. The objective of this study was to assess tolerability and perceived efficacy of a prototype CO2 delivery device in subjects with nasal congestion. Methods: Otherwise healthy subjects (N¼147), aged 18 years with a perception of nasal breathing score 70 mm (visual analog scale), had an initial administration of nasal CO2 at the investigator’s office (part 1), then received instructions for 6 additional days of self-treatment at home (part 2). Subjects documented at-home usage and symptom relief in a diary, and completed a 3-part questionnaire to record pre- and post-treatment experiences. All subjects provided written informed consent. Results: Most subjects in the per-protocol population (N¼133) were female and white, with a mean age of 51.8 years. After at-home use, 32% of subjects thought the nasal spray performed “much better than expected”; 95 subjects (71.4%) at least somewhat agreed that the nasal spray provided effective relief for nasal congestion, including 53 subjects (39.8%) who completely agreed. Similarly, 92 subjects (69.2%) at least somewhat agreed that the nasal spray provided instant relief, with 78 subjects (58.6%) indicating that they experienced some longlasting relief. User experience with self-treatment at home is summarized in the Table. The CO2 nasal spray was well tolerated; most adverse events were mild and consistent with previous studies. Conclusion: CO2 nasal spray was appealing to a subset of subjects with nasal congestion, with subjects reporting instant and longlasting symptom relief.
P327 THE DANGERS OF CHRONIC SINUSITIS: PHYSICIAN BEWARE N. Patel*, Pittsburgh, PA. Introduction: Isolated sphenoid diseases are rare, and secondary to the nonspecific character of their symptoms, they have previously been misdiagnosed. Herein we describe a case in which a patient was treated outpatient with several courses of antibiotics for chronic
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 117 (2016) S22eS124
P324 EFFICACY OF MP-AZEFLU IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS: IMPORTANCE OF CHILD SYMPTOM ASSESSMENT E. Sher*1, S. Gawchik2, S. Fineman3, W. Berger4, 1. Ocean, NJ; 2. Chester, PA; 3. Marietta, GA; 4. Mission Viejo, CA. Introduction: The primary objective of this study was to assess the efficacy of MP-AzeFlu for the treatment of children with SAR based on patient self-reporting of nasal and ocular symptoms. Methods: A total of 348 children 4 to 11 years with moderate-tosevere SAR were randomized to treatment with MP-AzeFlu (Meda) or placebo nasal sprays 1 spray/nostril bid (daily dose MP-AzeFlu group: AZE 548 mg; FP: 200 mg) in a randomized, placebo-controlled, parallel group, 14-day, double-blind trial. Efficacy endpoints were overall change from baseline in reflective total nasal symptom score (rTNSS, AM + PM), reflective total ocular symptom score (rTOSS), and in individual nasal and ocular symptom scores in children 6 to11 years (n¼304) recorded twice daily in eDiaries. These were analyzed post hoc by the degree of child self-rating compared to caregiver rating. Change in quality of life (QoL) was assessed by the pediatric quality of life questionnaire (PRQLQ). Results: MP-AzeFlu-treated children experienced a statistically superior (Diff -0.29; 95% CI -0.55, -0.04; p¼0.027) and clinically relevant improvement in QoL compared to placebo-treated children. As the extent of child self-rating increased compared to caregiver rating, so did the treatment difference between MP-AzeFlu and placebo. In the group which comprised >90% child self-rating (n¼82), MP-AzeFlu resulted in significantly better relief than placebo for nasal symptoms (p¼0.002), ocular symptoms (p¼0.009), and each individual nasal and ocular symptom assessed (p0.0355) (except rhinorrhea p¼0.064). Conclusion: MP-AzeFlu is an effective treatment for AR in children. A simple and child-specific tool to assess efficacy in pediatric AR trials is urgently needed.
P325 TIME TO A CLINICALLY-MEANINGFUL RESPONSE WITH MP-AZEFLU IN CHILDREN WITH SEASONAL ALLERGIC RHINITIS (SAR) T. Mahr1, E. Sher2, S. Gawchik3, S. Fineman4, W. Berger5, 1. La Crosse, WI; 2. Ocean, NJ; 3. Chester, PA; 4. Marietta, GA; 5. Mission Viejo, CA. Introduction: The efficacy of MP-AzeFlu was evaluated in children with moderate-to-severe SAR in a 2-week randomized, controlled trial. This analysis compared the proportion of children achieving ¼50% reduction in nasal symptoms and time taken to achieve that reduction following treatment with MP-AzeFlu or placebo (PLA). The importance of the child efficacy assessment is also addressed. Methods: 304 children 6 to 11 years of age were randomized into 14-day, double-blind trial of MP-AzeFlu (Meda) or PLA 1 spray/ nostril bid (daily dose MP-AzeFlu: AZE 548 mg; FP: 200 mg). Children or their caregivers recorded nasal symptom scores in an eDiary twice daily. Change from baseline in AM + PM rTNSS of 50% was the defined response and was assessed by degree of child self-rating. Time to response was analyzed by Kaplan-Meier estimates and log-rank tests post hoc. Quality of life (QoL) was assessed by the pediatric rhinoconjunctivitis quality of life questionnaire (PRQLQ). Results: MP-AzeFlu-treated children experienced a statistically superior (Diff -0.29; 95% CI -0.55, -0.04; p¼0.027) and clinicallyrelevant improvement in QoL compared to PLA-treated children. eDiary ratings demonstrated greater effect between MP-AzeFlu and PLA in children rating their own nasal symptoms for >90% of the time (n¼82). In this group, 38.9% of MP-AzeFlu children achieved response up to 10 days faster than PLA (10.9%; p¼0.0065).
Conclusion: MP-AzeFlu provided more complete and faster relief than PLA in children with AR. Efficacy in AR should be assessed in clinically-relevant ways but symptom severity should also be monitored using validated and reliable methods that children are capable of assessing themselves.
P326 A PHASE 2 CONSUMER EXPERIENCE STUDY OF A CARBON DIOXIDE NASAL SPRAY IN CONGESTED SUBJECTS S. Johnson*, A. Hamilton, R. Karwal, L. Lauersen, Parsippany, NJ. Introduction: Earlier clinical studies of allergic rhinitis have shown that relief of associated nasal symptoms is possible with nasally administered CO2. The objective of this study was to assess tolerability and perceived efficacy of a prototype CO2 delivery device in subjects with nasal congestion. Methods: Otherwise healthy subjects (N¼147), aged 18 years with a perception of nasal breathing score 70 mm (visual analog scale), had an initial administration of nasal CO2 at the investigator’s office (part 1), then received instructions for 6 additional days of self-treatment at home (part 2). Subjects documented at-home usage and symptom relief in a diary, and completed a 3-part questionnaire to record pre- and post-treatment experiences. All subjects provided written informed consent. Results: Most subjects in the per-protocol population (N¼133) were female and white, with a mean age of 51.8 years. After at-home use, 32% of subjects thought the nasal spray performed “much better than expected”; 95 subjects (71.4%) at least somewhat agreed that the nasal spray provided effective relief for nasal congestion, including 53 subjects (39.8%) who completely agreed. Similarly, 92 subjects (69.2%) at least somewhat agreed that the nasal spray provided instant relief, with 78 subjects (58.6%) indicating that they experienced some longlasting relief. User experience with self-treatment at home is summarized in the Table. The CO2 nasal spray was well tolerated; most adverse events were mild and consistent with previous studies. Conclusion: CO2 nasal spray was appealing to a subset of subjects with nasal congestion, with subjects reporting instant and longlasting symptom relief.
P327 THE DANGERS OF CHRONIC SINUSITIS: PHYSICIAN BEWARE N. Patel*, Pittsburgh, PA. Introduction: Isolated sphenoid diseases are rare, and secondary to the nonspecific character of their symptoms, they have previously been misdiagnosed. Herein we describe a case in which a patient was treated outpatient with several courses of antibiotics for chronic