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P430 Clinically significant improvement in mini-RQLQ scores in patients with nasal polyps after omalizumab initiation
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Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 119 (2017) S17eS96
P428 THE EMPTY NOSE SYNDROME (ENS): A DIAGNOSTIC AND THERAPEUTIC CHALLENGE FOR THE ALLERGIST-IMMUNOLOGIST T. Nsouli*, N. Diliberto, A. Nsouli, S. Nsouli, J. Bellanti, Washington, DC. Introduction: ENS is a rare rhinological disorder occurring months to years after sinonasal surgery, with symptoms of paradoxical nasal obstruction, nasal dryness, crusting, and dyspnea. Little is known of its pathogenesis, although anatomical changes leading to disruption of mucosal cooling, and disordered neurosensory mechanisms are strongly implicated. Medical therapies include mucosal humidification, irrigations, emollients, and surgical therapy with turbinate reconstruction reserved for refractory cases. Prevention of this condition through turbinate-sparing techniques is critical. Two subjects with ENS are described with a rational approach of management. Method: Two patients, 34 y/o WF and 28 y/o WM, were evaluated for sensation of nasal blockage, hyposmia and “suffocation” with frustration, fatigue and aprosexia, that occurred 8 and 11 months respectively post nasal turbinectomy. Both patients had been falsely diagnosed with psychosomatic disorders and were referred to psychiatrists. Results: Skin prick tests were positive for seasonal allergens and dust mites. Nasal endoscopy and CT of paranasal sinuses demonstrated nasal cavity widening and loss of the lower turbinate tissues. Treatment with environmental control, mupirocin nasal saline solution (0.05%), flunisolide aqueous nasal corticosteroid spray (25 mcg/spray), and a supportive clinical approach resulted in significant improvement. Mean average improvement percentiles (in both patients) were 63% for feeling of nasal blockage, 63% for fatigue and aprosexia, 60% for hyposmia, and 1% for nasal inspiratory peak flow rate. Conclusion: The management of patients with ENS requires collaborative teamwork between otolaryngologists and allergists and could be achieved by an initial allergy evaluation and treatment and, ultimately prevented with a careful turbinate-sparing technique. CT SCAN revealed significant widening of nasal passages as well as loss of turbinate tissue.
Introduction: Studies of the effects of guidelines in everyday practice are scarce. In a universalistic, government-lead system, as the Italian, the huge “allergy demand” produces a pressure on allergy services whose indicator is the lengthening of the waiting lists (WL). We used ARIA and GINA guidelines in an organizational intervention to reduce WL of children with respiratory allergy. Methods: A plan to cut-down WL and to increase the appropriateness of the referral to pediatric allergist (PA) was activated when our WL for allergy outpatients reached 12 months (January 2015). A ’filter’ outpatient clinic was entrusted to non-allergy-trained pediatricians (P) (Figure) Results: Between March 2015 and February 2016, 2195 patients: 1281 were sent by CC to PA, 914 to P. The WL for PA was cut from 360 to 220, 214 and 180 days at 6, 9, and 12 months respectively (p<0.001). The percentage of negative visits (children without allergic pathology at all) was 33% at time 0 and 10.5% after the intervention. The appropriateness of referral at PA level increased from 67% to 87%. Conclusions: The plan was able to cut the waiting list by 50%. PA’s commitment has been optimized. The plan obtained more attention to the referral by the GP, although no intervention has been made on this part of the sanitary system. The categories of ARIA and GINA can be used to rationalize the clinical governance of children with respiratory allergy.
P430 CLINICALLY SIGNIFICANT IMPROVEMENT IN MINI-RQLQ SCORES IN PATIENTS WITH NASAL POLYPS AFTER OMALIZUMAB INITIATION T. Carr*1, N. Griffin2, M. Yang2, K. Rosen2, T. Casale3, 1. Tucson, AZ; 2. South San Francisco, CA; 3. Tampa, FL.
P429 ARIA AND GINA IMPLEMENTATION IN A UNIVERSALISTIC HEALTH SYSTEM F. Lamarra, M. Mennini, L. Dahdah, R. Giampaolo, A. Campana, A. Fiocchi*, Rome, Holy See, Vatican City State.
Introduction: Nasal polyps are a relatively common comorbid condition associated with asthma. Little is known about how patients with both asthma and nasal polyps respond to omalizumab treatment. Methods: Asthma patients were enrolled in the multicenter, prospective, open-label single-arm 48-week observational study, PROSPERO. Patients initiated omalizumab treatment based on physician assessment of need. Comorbid conditions (patient reported), including nasal polyps were recorded at baseline. At baseline and at the end of study, patients completed MiniRhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). Changes (mean, SD) from baseline to end of study in MiniRQLQ were calculated in patients with and without nasal polyps, and further divided by whether or not they were receiving nasal or oral/ systemic steroids at enrollment. Results: 806 patients were enrolled in PROSPERO, of which 104 had a comorbid diagnosis of nasal polyps. Of those patients, 63.46% (66 /104) were receiving nasal corticosteroids and 15 (14.42%) both nasal and oral steroids. At baseline, there was no significant difference (p¼0.485) in mean MiniRQLQ scores between patients with
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 119 (2017) S17eS96
nasal polyps, regardless of their steroid status (table 1). At week 48, all patient groups improved in excess of the MID threshold of 0.4 units in MiniRQLQ (mean (SD): -0.87 (1.52), -1.23 (1.13), -0.99 (1.06), -1.02 (1.30). Adverse events were consistent with the known safety profile of omalizumab. Conclusion: Patients with asthma with and without comorbid nasal polyps experience clinically significant and meaningful improvements in MiniRQLQ scores after initiation on omalizumab regardless of baseline steroid burden.
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P432 USE OF HOME BIPAP FOR REFRACTORY VOCAL CORD DYSFUNCTION (VCD) M. Wahidi*1, W. Lee1, D. Khan2, 1. Dallas, TX; 2. Grapevine, TX. Introduction: VCD may be mistaken for anaphylaxis. Treatment of VCD is typically with speech therapy. Reassurance/supportive care may be used acutely for mild cases but more severe cases have been treated with heliox or CPAP. Methods: We present a patient with refractory VCD who responded to home BiPAP therapy. Results: A 33 yo woman presented with a history of recurrent “anaphylaxis”. Within 6 months she had 7 severe episodes, 5 resulting in intubation. Episodes began with chest flushing, and pruritus and within minutes she developed severe dyspnea with chest/throat tightness, and stridor. She also reported more frequent minor episodes that did not result in urgent care visits. No triggers were identified including foods, drugs, exercise, or insect stings. Review of prior medical records revealed no documented rash or hypoxia, but occasional mild hypercarbia on ABGs. Duration of intubation ranged between 12-24 hours and laryngoscopy after intubation showed no evidence of laryngeal edema. Serum tryptase was normal. Due to concerns for VCD, speech therapy was initiated with improvement in mild episodes but she continued to go the ED and was hospitalized for more severe episodes. Due to recurrent admissions despite speech therapy and lack of availability of heliox at local EDs, AUTO BiPAP was recommended (min 5, max 14, PS 5). Since using home BiPAP, she has not had any further hospitalizations or intubations for her VCD. Conclusion: For severe refractory cases of VCD, use of home BiPAP may be considered to potentially eliminate hospitalizations and intubations.
P431 NOVEL PHOTO-ELECTROCHEMICAL OXIDATION AIRPURIFIICATION TECHNOLOGY REDUCES NASAL AND OCULAR ALLERGY SYMPTOMS J. Wong1, N. Rao*1, S. Liggett2, Y. Goswami2, A. Kumar2, 1. San Francisco, CA; 2. Tampa, FL. Background: Photo-electrochemical oxidation (PECO) is a new air purification technology developed to reduce circulating indoor allergens. PECO removes particles as small as 30 nanometers with the destruction of organic matter otherwise not trapped by a traditional filter and removes volatile organic compounds. We hypothesized that with daily use, the device would reduce user nasal and ocular allergy total symptom scores within 4 weeks. Methods: The study was performed among 46 individuals with self-reported allergies. Self-reported total symptom scores (TSS) were calculated at baseline and weekly for 4 weeks following initiation of continuous use of the system. TSS was the sum of total nasal symptom scores (TNSS) and total ocular symptom scores (TOSS) for the week. Results: There was a statistically significant change in overall TSS from baseline to four weeks (10.1 at baseline and 4.35 post-intervention) resulting in a mean difference of 5.75 (95% CI 4.32 to 7.18; p<0.0001). There was a statistically significant change in TNSS score from baseline to four weeks (6.3 at baseline and 3.04 postintervention) resulting in a mean difference of 3.26 (95% CI 2.33 to 3.19; p<0.0001). There was a statistically significant change in TOSS score from baseline to four weeks (3.82 at baseline and 1.3 postintervention) resulting in a mean difference of 2.52 (95% CI 1.74 to 3.3; p<0.0001). Conclusions: With the use of PECO air purification technology, TSS, TNSS and TOSS scores decreased significantly. These improvements were consistent over the 4-week course of device use.
P433 EFFICACY AND SAFETY OF ONCE-DAILY AND TWICEDAILY OLOPATADINE/MOMETASONE NASAL SPRAY TREATMENT IN SEASONAL ALLERGIC RHINITIS C. Andrews*1, D. Mohar2, P. Agarwal3, Y. Salhi4, S. Tantry5, 1. San Antonio, TX; 2. Kerrville, TX; 3. Navi Mumbai, India; 4. Middlesex, United Kingdom; 5. Mahwah, NJ. Introduction: In patients with allergic rhinitis (AR), intranasal combination treatment with an antihistamine and a corticosteroid may provide improved symptom relief over monotherapy treatment. GSP301 nasal spray (NS) is a fixed-dose-combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate. Efficacy and safety of GSP301 once-daily (QD) or twice-daily (BID) were evaluated in this seasonal AR (SAR) study. Methods: In this randomized, double-blind, parallel-group study, patients (12 years) with SAR were equally randomized to GSP301 BID (olopatadine 665mg/mometasone 25mg), GSP301 QD (olopatadine 665mg/mometasone 50mg), olopatadine monotherapy (665mg BID or QD), mometasone monotherapy (25mg BID or 50mg QD), or placebo for 14 days. The primary endpointdmean change from baseline in AM and PM reflective total nasal symptom score (rTNSS)dwas analyzed using ANCOVA. Adverse events (AEs) were also assessed. Results: A total of 1,111 patients were randomized. GSP301 BID or QD treatment significantly improved rTNSS scores vs placebo (least square means difference [95% CI] GSP301 BID: -1.17 [-1.73, -0.61]; GSP301 QD: -1.11 [-1.67, 0.55]; P<0.0001, both). GSP301 BID treatment also showed significant improvement vs olopatadine ( 0.49 [-0.98, -0.00]; P¼0.049) and mometasone (-0.71 [-1.20, -0.22]; P¼0.004). The percentages of patients reporting treatment-emergent AEs were 10.8%, 9.5%, and 8.2%, with GSP301 BID, GSP301 QD, and placebo.
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 119 (2017) S17eS96
P428 THE EMPTY NOSE SYNDROME (ENS): A DIAGNOSTIC AND THERAPEUTIC CHALLENGE FOR THE ALLERGIST-IMMUNOLOGIST T. Nsouli*, N. Diliberto, A. Nsouli, S. Nsouli, J. Bellanti, Washington, DC. Introduction: ENS is a rare rhinological disorder occurring months to years after sinonasal surgery, with symptoms of paradoxical nasal obstruction, nasal dryness, crusting, and dyspnea. Little is known of its pathogenesis, although anatomical changes leading to disruption of mucosal cooling, and disordered neurosensory mechanisms are strongly implicated. Medical therapies include mucosal humidification, irrigations, emollients, and surgical therapy with turbinate reconstruction reserved for refractory cases. Prevention of this condition through turbinate-sparing techniques is critical. Two subjects with ENS are described with a rational approach of management. Method: Two patients, 34 y/o WF and 28 y/o WM, were evaluated for sensation of nasal blockage, hyposmia and “suffocation” with frustration, fatigue and aprosexia, that occurred 8 and 11 months respectively post nasal turbinectomy. Both patients had been falsely diagnosed with psychosomatic disorders and were referred to psychiatrists. Results: Skin prick tests were positive for seasonal allergens and dust mites. Nasal endoscopy and CT of paranasal sinuses demonstrated nasal cavity widening and loss of the lower turbinate tissues. Treatment with environmental control, mupirocin nasal saline solution (0.05%), flunisolide aqueous nasal corticosteroid spray (25 mcg/spray), and a supportive clinical approach resulted in significant improvement. Mean average improvement percentiles (in both patients) were 63% for feeling of nasal blockage, 63% for fatigue and aprosexia, 60% for hyposmia, and 1% for nasal inspiratory peak flow rate. Conclusion: The management of patients with ENS requires collaborative teamwork between otolaryngologists and allergists and could be achieved by an initial allergy evaluation and treatment and, ultimately prevented with a careful turbinate-sparing technique. CT SCAN revealed significant widening of nasal passages as well as loss of turbinate tissue.
Introduction: Studies of the effects of guidelines in everyday practice are scarce. In a universalistic, government-lead system, as the Italian, the huge “allergy demand” produces a pressure on allergy services whose indicator is the lengthening of the waiting lists (WL). We used ARIA and GINA guidelines in an organizational intervention to reduce WL of children with respiratory allergy. Methods: A plan to cut-down WL and to increase the appropriateness of the referral to pediatric allergist (PA) was activated when our WL for allergy outpatients reached 12 months (January 2015). A ’filter’ outpatient clinic was entrusted to non-allergy-trained pediatricians (P) (Figure) Results: Between March 2015 and February 2016, 2195 patients: 1281 were sent by CC to PA, 914 to P. The WL for PA was cut from 360 to 220, 214 and 180 days at 6, 9, and 12 months respectively (p<0.001). The percentage of negative visits (children without allergic pathology at all) was 33% at time 0 and 10.5% after the intervention. The appropriateness of referral at PA level increased from 67% to 87%. Conclusions: The plan was able to cut the waiting list by 50%. PA’s commitment has been optimized. The plan obtained more attention to the referral by the GP, although no intervention has been made on this part of the sanitary system. The categories of ARIA and GINA can be used to rationalize the clinical governance of children with respiratory allergy.
P430 CLINICALLY SIGNIFICANT IMPROVEMENT IN MINI-RQLQ SCORES IN PATIENTS WITH NASAL POLYPS AFTER OMALIZUMAB INITIATION T. Carr*1, N. Griffin2, M. Yang2, K. Rosen2, T. Casale3, 1. Tucson, AZ; 2. South San Francisco, CA; 3. Tampa, FL.
P429 ARIA AND GINA IMPLEMENTATION IN A UNIVERSALISTIC HEALTH SYSTEM F. Lamarra, M. Mennini, L. Dahdah, R. Giampaolo, A. Campana, A. Fiocchi*, Rome, Holy See, Vatican City State.
Introduction: Nasal polyps are a relatively common comorbid condition associated with asthma. Little is known about how patients with both asthma and nasal polyps respond to omalizumab treatment. Methods: Asthma patients were enrolled in the multicenter, prospective, open-label single-arm 48-week observational study, PROSPERO. Patients initiated omalizumab treatment based on physician assessment of need. Comorbid conditions (patient reported), including nasal polyps were recorded at baseline. At baseline and at the end of study, patients completed MiniRhinoconjunctivitis Quality of Life Questionnaire (MiniRQLQ). Changes (mean, SD) from baseline to end of study in MiniRQLQ were calculated in patients with and without nasal polyps, and further divided by whether or not they were receiving nasal or oral/ systemic steroids at enrollment. Results: 806 patients were enrolled in PROSPERO, of which 104 had a comorbid diagnosis of nasal polyps. Of those patients, 63.46% (66 /104) were receiving nasal corticosteroids and 15 (14.42%) both nasal and oral steroids. At baseline, there was no significant difference (p¼0.485) in mean MiniRQLQ scores between patients with
Abstracts: Poster Sessions / Ann Allergy Asthma Immunol 119 (2017) S17eS96
nasal polyps, regardless of their steroid status (table 1). At week 48, all patient groups improved in excess of the MID threshold of 0.4 units in MiniRQLQ (mean (SD): -0.87 (1.52), -1.23 (1.13), -0.99 (1.06), -1.02 (1.30). Adverse events were consistent with the known safety profile of omalizumab. Conclusion: Patients with asthma with and without comorbid nasal polyps experience clinically significant and meaningful improvements in MiniRQLQ scores after initiation on omalizumab regardless of baseline steroid burden.
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P432 USE OF HOME BIPAP FOR REFRACTORY VOCAL CORD DYSFUNCTION (VCD) M. Wahidi*1, W. Lee1, D. Khan2, 1. Dallas, TX; 2. Grapevine, TX. Introduction: VCD may be mistaken for anaphylaxis. Treatment of VCD is typically with speech therapy. Reassurance/supportive care may be used acutely for mild cases but more severe cases have been treated with heliox or CPAP. Methods: We present a patient with refractory VCD who responded to home BiPAP therapy. Results: A 33 yo woman presented with a history of recurrent “anaphylaxis”. Within 6 months she had 7 severe episodes, 5 resulting in intubation. Episodes began with chest flushing, and pruritus and within minutes she developed severe dyspnea with chest/throat tightness, and stridor. She also reported more frequent minor episodes that did not result in urgent care visits. No triggers were identified including foods, drugs, exercise, or insect stings. Review of prior medical records revealed no documented rash or hypoxia, but occasional mild hypercarbia on ABGs. Duration of intubation ranged between 12-24 hours and laryngoscopy after intubation showed no evidence of laryngeal edema. Serum tryptase was normal. Due to concerns for VCD, speech therapy was initiated with improvement in mild episodes but she continued to go the ED and was hospitalized for more severe episodes. Due to recurrent admissions despite speech therapy and lack of availability of heliox at local EDs, AUTO BiPAP was recommended (min 5, max 14, PS 5). Since using home BiPAP, she has not had any further hospitalizations or intubations for her VCD. Conclusion: For severe refractory cases of VCD, use of home BiPAP may be considered to potentially eliminate hospitalizations and intubations.
P431 NOVEL PHOTO-ELECTROCHEMICAL OXIDATION AIRPURIFIICATION TECHNOLOGY REDUCES NASAL AND OCULAR ALLERGY SYMPTOMS J. Wong1, N. Rao*1, S. Liggett2, Y. Goswami2, A. Kumar2, 1. San Francisco, CA; 2. Tampa, FL. Background: Photo-electrochemical oxidation (PECO) is a new air purification technology developed to reduce circulating indoor allergens. PECO removes particles as small as 30 nanometers with the destruction of organic matter otherwise not trapped by a traditional filter and removes volatile organic compounds. We hypothesized that with daily use, the device would reduce user nasal and ocular allergy total symptom scores within 4 weeks. Methods: The study was performed among 46 individuals with self-reported allergies. Self-reported total symptom scores (TSS) were calculated at baseline and weekly for 4 weeks following initiation of continuous use of the system. TSS was the sum of total nasal symptom scores (TNSS) and total ocular symptom scores (TOSS) for the week. Results: There was a statistically significant change in overall TSS from baseline to four weeks (10.1 at baseline and 4.35 post-intervention) resulting in a mean difference of 5.75 (95% CI 4.32 to 7.18; p<0.0001). There was a statistically significant change in TNSS score from baseline to four weeks (6.3 at baseline and 3.04 postintervention) resulting in a mean difference of 3.26 (95% CI 2.33 to 3.19; p<0.0001). There was a statistically significant change in TOSS score from baseline to four weeks (3.82 at baseline and 1.3 postintervention) resulting in a mean difference of 2.52 (95% CI 1.74 to 3.3; p<0.0001). Conclusions: With the use of PECO air purification technology, TSS, TNSS and TOSS scores decreased significantly. These improvements were consistent over the 4-week course of device use.
P433 EFFICACY AND SAFETY OF ONCE-DAILY AND TWICEDAILY OLOPATADINE/MOMETASONE NASAL SPRAY TREATMENT IN SEASONAL ALLERGIC RHINITIS C. Andrews*1, D. Mohar2, P. Agarwal3, Y. Salhi4, S. Tantry5, 1. San Antonio, TX; 2. Kerrville, TX; 3. Navi Mumbai, India; 4. Middlesex, United Kingdom; 5. Mahwah, NJ. Introduction: In patients with allergic rhinitis (AR), intranasal combination treatment with an antihistamine and a corticosteroid may provide improved symptom relief over monotherapy treatment. GSP301 nasal spray (NS) is a fixed-dose-combination of the antihistamine olopatadine hydrochloride and the corticosteroid mometasone furoate. Efficacy and safety of GSP301 once-daily (QD) or twice-daily (BID) were evaluated in this seasonal AR (SAR) study. Methods: In this randomized, double-blind, parallel-group study, patients (12 years) with SAR were equally randomized to GSP301 BID (olopatadine 665mg/mometasone 25mg), GSP301 QD (olopatadine 665mg/mometasone 50mg), olopatadine monotherapy (665mg BID or QD), mometasone monotherapy (25mg BID or 50mg QD), or placebo for 14 days. The primary endpointdmean change from baseline in AM and PM reflective total nasal symptom score (rTNSS)dwas analyzed using ANCOVA. Adverse events (AEs) were also assessed. Results: A total of 1,111 patients were randomized. GSP301 BID or QD treatment significantly improved rTNSS scores vs placebo (least square means difference [95% CI] GSP301 BID: -1.17 [-1.73, -0.61]; GSP301 QD: -1.11 [-1.67, 0.55]; P<0.0001, both). GSP301 BID treatment also showed significant improvement vs olopatadine ( 0.49 [-0.98, -0.00]; P¼0.049) and mometasone (-0.71 [-1.20, -0.22]; P¼0.004). The percentages of patients reporting treatment-emergent AEs were 10.8%, 9.5%, and 8.2%, with GSP301 BID, GSP301 QD, and placebo.