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formoterol pressurized metered-dose inhaler versus budesonide alone in children (6-<12 years) with asthma
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Abstracts: Oral Concurrent Sessions / Ann Allergy Asthma Immunol 117 (2016) S1eS21
Conclusion: Preliminary findings from this post-hoc analysis suggest omalizumab may confer a protective effect on lung function in children experiencing exacerbations. Additional longitudinal analyses are needed to confirm these findings.
Change from Baseline in Percent Predicted Pre-bronchodilator FEV1 by Exacerbation Status and Treatment During Weeks 1e52
Change from baseline in lung function and incidence of protocol-defined asthma exacerbations by treatment group.
O022
O021 EFFICACY OF BUDESONIDE/FORMOTEROL PRESSURIZED METERED-DOSE INHALER VERSUS BUDESONIDE ALONE IN CHILDREN (6-<12 YEARS) WITH ASTHMA D. Pearlman*1, G. Eckerwall2, J. McLaren3, R. Lamarca4, M. Puu2, C. Jorup2, K. Sandin2, M. Lanz5, 1. Denver, CO; 2. Gothenburg, Sweden; 3. Gaithersburg, MD; 4. Barcelona, Spain; 5. Coral Gables, FL. Introduction: Budesonide/formoterol (BUD/FM) pMDI is indicated in patients aged >¼12 years with asthma. This study evaluated efficacy of two FM doses added to BUD as fixed combinations versus BUD in asthmatic children. Methods: This randomized, double-blind, parallel-group, multicenter study (NCT02091986) included 6-<12-year-old asthmatic children previously receiving either medium-dose ICS or ICS/LABA. Children symptomatic during a 7-28-day run-in on 1 inhalation of BUD DPI 90 mg twice daily (BID) were randomized to receive 2 inhalations BID of BUD/FM pMDI 80/4.5 mg (n¼92), BUD/FM pMDI 80/2.25 mg (n¼95), or BUD pMDI 80 mg (n¼92) for 12 weeks. The primary efficacy variable was change from baseline to week 12 in 1-hour post-dose clinic FEV1. Results: Changes from baseline to week 12 in 1-hour post-dose FEV1 (primary) and 15-minute post-dose FEV1 were statistically significantly greater with BUD/FM 80/4.5 mg versus BUD (both p<¼0.015, Table), but not BUD/FM 80/2.25 mg versus BUD. Bronchodilatory effects evident 15 minutes post-dose on day 1 were maintained at week 12. Changes from baseline to week 12 in 1-hour post-dose FEF25%-75% were significantly greater with both BUD/FM doses versus BUD (p<¼0.005). The change from baseline in 1-hour post-dose PEF was superior with BUD/FM 80/ 4.5 mg versus other treatments (p<0.05). Incidence of protocoldefined asthma exacerbations and changes from baseline in asthma symptom-related outcomes and FVC were similar across treatments. Conclusion: BUD/FM 80/4.5 mg treatment resulted in significant improvements in lung function versus BUD 80 mg, demonstrating appropriateness as step-up therapy for children aged 6-<12 years with asthma symptomatic on ICS. Supported by AstraZeneca LP.
THE RELATIONSHIP BETWEEN ASTHMA AND FOOD DESERTS IN THE HAMPTON ROADS AREA D. Preston*1, M. Morales2, A. Plunk3, 1. Charlottesville, VA; 2. Suffolk, VA; 3. Norfolk, VA. Introduction: Our goal was to compare the prevalence of pediatric asthma between groups of patients by food desert status, while controlling for allergic rhinitis and overweight/obesity. We hypothesized that the prevalence of asthma will be higher in food deserts. Methods: This retrospective chart review of patients, aged 6 to 18 years, who were seen between 01/01/2014 and 03/31/2015 for well-child/routine immunization visits. 2043 patients were included and food desert status was determined using the USDA Food Access Research Atlas tool. We modeled the relationship using logistic regression. Results: 57.81% of the sample (n¼1181) lived at least 0.5 miles away from a grocery store, while 10.87% of the sample (n¼222) lived at least one mile away form a grocery store. 21% of the children within this sample who lived in a food desert have asthma, compared to 17% asthma rate for the children who did not live in a food desert. Living farther than a mile from a grocery store was associated with 53% higher odds of having asthma, after controlling for obesity and allergic rhinitis (OR ¼ 1.53, 95% CI [1.06,2.23], p¼0.022), compared to children who did not live in a food desert. Living between the 0.5 mile to 1 mile designation from a grocery store, or whole food source, was not significantly related to asthma. Conclusions: Our study shows that living farther than one mile from a grocery store could modify risk for asthma development. Further study is needed to identify how access to fresh foods impacts asthma risk.
O023 THE RELATIONSHIP OF SALIVARY COTININE CONCENTRATIONS TO ASTHMA SYMPTOMS IN RURAL GEORGIA HIGH SCHOOL STUDENTS L. Green*, S. Looney, D. Ownby, M. Tingen, Augusta, GA. Introduction: Secondhand smoke exposure is known to affect the frequency and severity of childhood asthma symptoms. Cotinine, the primary nicotine metabolite, serves as a biomarker of secondhand smoke exposure and could potentially identify pediatric patients at risk for more severe asthma symptoms. We sought to investigate how well salivary cotinine measurements correlate
Abstracts: Oral Concurrent Sessions / Ann Allergy Asthma Immunol 117 (2016) S1eS21
Conclusion: Preliminary findings from this post-hoc analysis suggest omalizumab may confer a protective effect on lung function in children experiencing exacerbations. Additional longitudinal analyses are needed to confirm these findings.
Change from Baseline in Percent Predicted Pre-bronchodilator FEV1 by Exacerbation Status and Treatment During Weeks 1e52
Change from baseline in lung function and incidence of protocol-defined asthma exacerbations by treatment group.
O022
O021 EFFICACY OF BUDESONIDE/FORMOTEROL PRESSURIZED METERED-DOSE INHALER VERSUS BUDESONIDE ALONE IN CHILDREN (6-<12 YEARS) WITH ASTHMA D. Pearlman*1, G. Eckerwall2, J. McLaren3, R. Lamarca4, M. Puu2, C. Jorup2, K. Sandin2, M. Lanz5, 1. Denver, CO; 2. Gothenburg, Sweden; 3. Gaithersburg, MD; 4. Barcelona, Spain; 5. Coral Gables, FL. Introduction: Budesonide/formoterol (BUD/FM) pMDI is indicated in patients aged >¼12 years with asthma. This study evaluated efficacy of two FM doses added to BUD as fixed combinations versus BUD in asthmatic children. Methods: This randomized, double-blind, parallel-group, multicenter study (NCT02091986) included 6-<12-year-old asthmatic children previously receiving either medium-dose ICS or ICS/LABA. Children symptomatic during a 7-28-day run-in on 1 inhalation of BUD DPI 90 mg twice daily (BID) were randomized to receive 2 inhalations BID of BUD/FM pMDI 80/4.5 mg (n¼92), BUD/FM pMDI 80/2.25 mg (n¼95), or BUD pMDI 80 mg (n¼92) for 12 weeks. The primary efficacy variable was change from baseline to week 12 in 1-hour post-dose clinic FEV1. Results: Changes from baseline to week 12 in 1-hour post-dose FEV1 (primary) and 15-minute post-dose FEV1 were statistically significantly greater with BUD/FM 80/4.5 mg versus BUD (both p<¼0.015, Table), but not BUD/FM 80/2.25 mg versus BUD. Bronchodilatory effects evident 15 minutes post-dose on day 1 were maintained at week 12. Changes from baseline to week 12 in 1-hour post-dose FEF25%-75% were significantly greater with both BUD/FM doses versus BUD (p<¼0.005). The change from baseline in 1-hour post-dose PEF was superior with BUD/FM 80/ 4.5 mg versus other treatments (p<0.05). Incidence of protocoldefined asthma exacerbations and changes from baseline in asthma symptom-related outcomes and FVC were similar across treatments. Conclusion: BUD/FM 80/4.5 mg treatment resulted in significant improvements in lung function versus BUD 80 mg, demonstrating appropriateness as step-up therapy for children aged 6-<12 years with asthma symptomatic on ICS. Supported by AstraZeneca LP.
THE RELATIONSHIP BETWEEN ASTHMA AND FOOD DESERTS IN THE HAMPTON ROADS AREA D. Preston*1, M. Morales2, A. Plunk3, 1. Charlottesville, VA; 2. Suffolk, VA; 3. Norfolk, VA. Introduction: Our goal was to compare the prevalence of pediatric asthma between groups of patients by food desert status, while controlling for allergic rhinitis and overweight/obesity. We hypothesized that the prevalence of asthma will be higher in food deserts. Methods: This retrospective chart review of patients, aged 6 to 18 years, who were seen between 01/01/2014 and 03/31/2015 for well-child/routine immunization visits. 2043 patients were included and food desert status was determined using the USDA Food Access Research Atlas tool. We modeled the relationship using logistic regression. Results: 57.81% of the sample (n¼1181) lived at least 0.5 miles away from a grocery store, while 10.87% of the sample (n¼222) lived at least one mile away form a grocery store. 21% of the children within this sample who lived in a food desert have asthma, compared to 17% asthma rate for the children who did not live in a food desert. Living farther than a mile from a grocery store was associated with 53% higher odds of having asthma, after controlling for obesity and allergic rhinitis (OR ¼ 1.53, 95% CI [1.06,2.23], p¼0.022), compared to children who did not live in a food desert. Living between the 0.5 mile to 1 mile designation from a grocery store, or whole food source, was not significantly related to asthma. Conclusions: Our study shows that living farther than one mile from a grocery store could modify risk for asthma development. Further study is needed to identify how access to fresh foods impacts asthma risk.
O023 THE RELATIONSHIP OF SALIVARY COTININE CONCENTRATIONS TO ASTHMA SYMPTOMS IN RURAL GEORGIA HIGH SCHOOL STUDENTS L. Green*, S. Looney, D. Ownby, M. Tingen, Augusta, GA. Introduction: Secondhand smoke exposure is known to affect the frequency and severity of childhood asthma symptoms. Cotinine, the primary nicotine metabolite, serves as a biomarker of secondhand smoke exposure and could potentially identify pediatric patients at risk for more severe asthma symptoms. We sought to investigate how well salivary cotinine measurements correlate