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A Retrospective Analysis of Anti-Allergy Drug Efficacy tested in an Environmental Exposure Chamber (EEC) Model compared to that observed in the Traditional Allergy Field Trials demonstrates the clinical relevance of allergen exposure models
Abstracts AB207
J ALLERGY CLIN IMMUNOL VOLUME 129, NUMBER 2
A Retrospective Analysis of Anti-Allergy Drug Efficacy tested in an Environmental Exposure Chamber (EEC) Model compared to that observed in the Traditional Allergy Field Trials demonstrates the clinical relevance of allergen exposure models A. Salapatek, N. Camuso, A. Amhed, V. Nelson; Cetero Research, Mississauga, ON, CANADA. RATIONALE: The well-controlled allergen exposure in the Environmental Exposure Chamber (EEC) model provides significant advantages for testing allergy medications compared to the study of patients in their everyday lives with variable allergen exposures. We examined whether the magnitude efficacy shown in the EEC model was comparable to that observed in traditional field trials. METHODS: Retrospective analysis of EEC data efficacies for the major drug classes of nasal spray antihistamines and corticosteroids was performed. Published drug efficacies for the same products were estimated and compared for EEC studies and traditional field trials. Data outcomes for nasal symptoms were scaled to be comparable where scoring systems differed. Data was standardized by calculating the treatment effect over the average baseline scores (percent treatment effect). RESULTS: Similar treatment effects were seen for each treatment class when one-day treatment effects in the EEC and field trials were compared. For the antihistamines olopatadine and azelastine, the EEC studies resulted in a 17.38% and 15.62% symptom reduction, compared to 20.2% and 15.22% in field trials, respectively. Mometasone, budesonide and ciclesonide had treatment effects of 8.11%, 9.33% and 5.05%, respectively when studied in an EEC, compared to 10.42%, 11.38% and 5.28% respectively, for field trials. CONCLUSIONS: These data indicate that anti-allergy drug efficacy tested in the EEC is comparable to those observed in patients’ everyday lives seen in the traditional field trial and thereby provides clinically relevant information for drug testing. These results support the use of the EEC model and outcomes towards all clinical phases of anti-allergy drug testing.
779
Online Allergy Surveys - is There an App For That? A Quantitative and Qualitative Study of Allergic Rhinitis Patients During a Pollen Season D. A. Dalan; Allergy and Asthma Care Center, fargo, ND. RATIONALE: Consistent with Health-Web 2.0, we aimed to engage patients in their arena and encourage real time monitoring through an electronic rhinitis outcomes questionnaire (eROQ) app during a pollen season, and evaluated use case perception and attitudes. METHODS: Online hits measured from our website, Facebook and Google advertisement analytics, and the National Allergy Bureau (NAB) pollen counts were analyzed in 2011. Allergy patient’s (eROQ) were recorded from our EHRs clinic kiosk and from an Apple I pad 2 app. Thirty six allergic rhinitis patients agreed to be interviewed. Triangulation methods consisted of observation, personal and focus group interviews. Signals gathered were formally analyzed for relationships and statistical significance. Interviews were transcribed and analyzed for themes. RESULTS: Correlations (Spearman’s r, p) between: Clinic hits: Google impressions (0.4, <0.0001), Facebook frequency: total pollens, (0.3, 0.03), Facebook reach: Google impressions ((0.4, <0.0001), and Facebook reach: clinic hits (0.4, 0.0002) all revealed significant correlations using non parametric methods. Patient eROQ symptom show statistical relationships with total pollen, specific grass and ragweed counts with correlations and ANOVA (p<0.05). Patient interviews revealed ease, trust, and willingness with the use of online surveys through an iPad app, and found the process to be fast and preferable. CONCLUSIONS: Relationships between online hits, symptoms, and pollen counts are a new phenomenon of Health-Web 2.0. Along with qualitative studies showing preference, ease, trust, and willingness to use online apps, real time monitoring of patients at home is facilitated. A relational database of this information interfaced with EHRs will facilitate the study of environment-clinic-pheno-genotype relationships.
780
A Personalized Care Platform: Incorporating Structured Data In Allergy Clinical Care J. Meng1, C. Barnes2, C. Ciaccio1, J. Portnoy2, K. Kelly2, G. A. Salzman3, T. Carver4, P. Dowling2, B. Jones2, M. Amado2, C. Miller2, K. Kennedy2, L. J. Rosenwasser1; 1Pediatric Immunology Research, Division of Allergy Clinics, the Children’s Mercy Hospital, Kansas City, MO, 2Division of Allergy Clinics, the Children’s Mercy Hospital, Kansas City, MO, 3Respiratory and Critical Care Medicine, UMKC School of Medicine, Kansas City, MO, 4Division of Pediatric Pulmonary and Respiratory Care, Children’s Mercy Hospital, Kansas City, MO. RATIONALE: The incidence, development, severity, treatment response and prognosis of allergic diseases are believed to be influenced by interaction of various environmental and genetic factors. Personalized medicine requires that health care is based on unique individual information including clinical, genetic, genomic and environmental factors. The unstructured data collected in clinical care lack consistency and comparability among care providers and lack accuracy to support clinical care. Incorporating structured data in medical electronic records could support personalized medical care in allergic diseases. METHODS: To identify various factors in medical and family history, living environment, use of medicine and knowledge of allergy that may be helpful for identification of etiology, diagnosis, and treatment, defined questions and answers were carefully designed and refined according to national and international allergic disease guidelines and currently used clinical care forms. The resulted questionnaires with specific disease patterns and symptom scales were integrated into the Asthma and Allergy Personalized Care system by information technology. RESULTS: A patient or patient guardian can answer general and symptom review questionnaires through a website linked to the system. This dynamic system responds to previous answers and allows patients to fill out additional disease specific forms and update relevant information. The information obtained can be reviewed and updated by assigned care providers to facilitate diagnosis and treatment. CONCLUSIONS: The incorporation of structured data provides not only accurate, consistent and standardized data for clinical care, but also offers data resources for translation research linked to clinical care.
MONDAY
778
J ALLERGY CLIN IMMUNOL VOLUME 129, NUMBER 2
A Retrospective Analysis of Anti-Allergy Drug Efficacy tested in an Environmental Exposure Chamber (EEC) Model compared to that observed in the Traditional Allergy Field Trials demonstrates the clinical relevance of allergen exposure models A. Salapatek, N. Camuso, A. Amhed, V. Nelson; Cetero Research, Mississauga, ON, CANADA. RATIONALE: The well-controlled allergen exposure in the Environmental Exposure Chamber (EEC) model provides significant advantages for testing allergy medications compared to the study of patients in their everyday lives with variable allergen exposures. We examined whether the magnitude efficacy shown in the EEC model was comparable to that observed in traditional field trials. METHODS: Retrospective analysis of EEC data efficacies for the major drug classes of nasal spray antihistamines and corticosteroids was performed. Published drug efficacies for the same products were estimated and compared for EEC studies and traditional field trials. Data outcomes for nasal symptoms were scaled to be comparable where scoring systems differed. Data was standardized by calculating the treatment effect over the average baseline scores (percent treatment effect). RESULTS: Similar treatment effects were seen for each treatment class when one-day treatment effects in the EEC and field trials were compared. For the antihistamines olopatadine and azelastine, the EEC studies resulted in a 17.38% and 15.62% symptom reduction, compared to 20.2% and 15.22% in field trials, respectively. Mometasone, budesonide and ciclesonide had treatment effects of 8.11%, 9.33% and 5.05%, respectively when studied in an EEC, compared to 10.42%, 11.38% and 5.28% respectively, for field trials. CONCLUSIONS: These data indicate that anti-allergy drug efficacy tested in the EEC is comparable to those observed in patients’ everyday lives seen in the traditional field trial and thereby provides clinically relevant information for drug testing. These results support the use of the EEC model and outcomes towards all clinical phases of anti-allergy drug testing.
779
Online Allergy Surveys - is There an App For That? A Quantitative and Qualitative Study of Allergic Rhinitis Patients During a Pollen Season D. A. Dalan; Allergy and Asthma Care Center, fargo, ND. RATIONALE: Consistent with Health-Web 2.0, we aimed to engage patients in their arena and encourage real time monitoring through an electronic rhinitis outcomes questionnaire (eROQ) app during a pollen season, and evaluated use case perception and attitudes. METHODS: Online hits measured from our website, Facebook and Google advertisement analytics, and the National Allergy Bureau (NAB) pollen counts were analyzed in 2011. Allergy patient’s (eROQ) were recorded from our EHRs clinic kiosk and from an Apple I pad 2 app. Thirty six allergic rhinitis patients agreed to be interviewed. Triangulation methods consisted of observation, personal and focus group interviews. Signals gathered were formally analyzed for relationships and statistical significance. Interviews were transcribed and analyzed for themes. RESULTS: Correlations (Spearman’s r, p) between: Clinic hits: Google impressions (0.4, <0.0001), Facebook frequency: total pollens, (0.3, 0.03), Facebook reach: Google impressions ((0.4, <0.0001), and Facebook reach: clinic hits (0.4, 0.0002) all revealed significant correlations using non parametric methods. Patient eROQ symptom show statistical relationships with total pollen, specific grass and ragweed counts with correlations and ANOVA (p<0.05). Patient interviews revealed ease, trust, and willingness with the use of online surveys through an iPad app, and found the process to be fast and preferable. CONCLUSIONS: Relationships between online hits, symptoms, and pollen counts are a new phenomenon of Health-Web 2.0. Along with qualitative studies showing preference, ease, trust, and willingness to use online apps, real time monitoring of patients at home is facilitated. A relational database of this information interfaced with EHRs will facilitate the study of environment-clinic-pheno-genotype relationships.
780
A Personalized Care Platform: Incorporating Structured Data In Allergy Clinical Care J. Meng1, C. Barnes2, C. Ciaccio1, J. Portnoy2, K. Kelly2, G. A. Salzman3, T. Carver4, P. Dowling2, B. Jones2, M. Amado2, C. Miller2, K. Kennedy2, L. J. Rosenwasser1; 1Pediatric Immunology Research, Division of Allergy Clinics, the Children’s Mercy Hospital, Kansas City, MO, 2Division of Allergy Clinics, the Children’s Mercy Hospital, Kansas City, MO, 3Respiratory and Critical Care Medicine, UMKC School of Medicine, Kansas City, MO, 4Division of Pediatric Pulmonary and Respiratory Care, Children’s Mercy Hospital, Kansas City, MO. RATIONALE: The incidence, development, severity, treatment response and prognosis of allergic diseases are believed to be influenced by interaction of various environmental and genetic factors. Personalized medicine requires that health care is based on unique individual information including clinical, genetic, genomic and environmental factors. The unstructured data collected in clinical care lack consistency and comparability among care providers and lack accuracy to support clinical care. Incorporating structured data in medical electronic records could support personalized medical care in allergic diseases. METHODS: To identify various factors in medical and family history, living environment, use of medicine and knowledge of allergy that may be helpful for identification of etiology, diagnosis, and treatment, defined questions and answers were carefully designed and refined according to national and international allergic disease guidelines and currently used clinical care forms. The resulted questionnaires with specific disease patterns and symptom scales were integrated into the Asthma and Allergy Personalized Care system by information technology. RESULTS: A patient or patient guardian can answer general and symptom review questionnaires through a website linked to the system. This dynamic system responds to previous answers and allows patients to fill out additional disease specific forms and update relevant information. The information obtained can be reviewed and updated by assigned care providers to facilitate diagnosis and treatment. CONCLUSIONS: The incorporation of structured data provides not only accurate, consistent and standardized data for clinical care, but also offers data resources for translation research linked to clinical care.
MONDAY
778