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Treatment of Inhaled Corticosteroid and Leukotriene Receptor Antagonistin Korean Young Cough-Variant Asthma Children
Abstracts S93
J ALLERGY CLIN IMMUNOL VOLUME 117, NUMBER 2
Budesonide and Montelukast Once Daily Inhibits ExerciseInduced Bronchoconstriction in 6- to 18-Year-Old Children with Asthma T. Grzelewski, J. Jerzynska, I. Stelmach; Department of Pediatrics and Allergy, Medical University of Lodz, M Curie Hospital, Zgierz, POLAND. RATIONALE: To determine whether budesonide and montelukast attenuate exercise-induced bronchoconstriction (EIB) in 6- to 18-year-old children with asthma. METHODS: Randomized, double blind, placebo controlled, single center trial. Children (n = 25) with forced expiratory volume in 1 second (FEV1) 70% of the predicted value and a fall in FEV1 20% after exercise on 2 occasions. Patients received budesonide 200 g/dose one puff and montelukast 5 mg tablets in children aged 6-14 or 10 mg tablets in children over 14 years old (n=12) or placebo (n=13) once daily for 4 weeks. Standardized exercise challenges were performed 24 hours after the last dose. End points included area above the postexercise percent fall in FEV1 versus time curve (AAC0-20min), maximum percent fall in FEV1 from pre-exercise baseline, and time to recovery of FEV1 to within 5% of pre-exercise baseline. RESULTS: Budesonide and montelukast significantly reduced AAC0-20min ( 171 vs 610 % x min for budesonide with montelukast and placebo, respectively, P < 0.05 ) and the maximum percent fall (11% vs 36% for budesonide with montelukast and placebo, respectively, P < 0.05). Budesonide and montelukast treatment resulted in a shorter time to recovery (6 vs 19 minutes for budesonide with montelukast and placebo, respectively, P <0.05 ). CONCLUSIONS: Budesonide and montelukast attenuate EIB in 6- to 18-year-old children with asthma.
361
Treatment of Inhaled Corticosteroid and Leukotriene Receptor Antagonistin Korean Young Cough-Variant Asthma Children J. Jung1, J. Lee2, J. Kim3; 1Dong-A University Hospital, Busan, REPUBLIC OF KOREA, 2Masan Samsung Hospital, Masan, REPUBLIC OF KOREA, 3Ulsa University Hospital, Ulsan, REPUBLIC OF KOREA. RATIONALE: Cough-variant asthma (CVA) is a common cause of chronic cough in young children. Some children who have CVA eventually become classic asthma. We evaluated the effect of inhaled corticosteroid and leukotriene receptor antagonist in young children who are suspected as CVA. METHODS: Forty cough-variant asthma patients who were younger than 5-years-old were enrolled in study. Fifteen were treated with pulmicort nebulization (500g, bid) for 4 weeks (Group A). Fourteen were treated with leukotriene receptor antagonist (Singulair, 4mg) for 4 weeks (Group B). Eleven were treated with intermittent short-acting 2-agonist nebulization (control). We evaluated the mean change of symptom score in night cough and sleep disturbance. RESULTS: There were no differences in age, sex, total IgE, total eosinophil count, duration of cough among 3 groups. Group A and B showed significant improvement of night cough and sleep disturbance after treatment. (p<0.05) In Group A and B, night cough was significantly improved after treatment more than in control. (P<0.05) But the improvement of sleep disturbance didn’t have no signigicant differences between three groups. (P=1.0) CONCLUSIONS: Inhaled corticosteroid and leukotriene receptor antagonist are effective to control of chronic cough in CVA children who are younger than 5-years-old.
362
Early Intervention with High-Dose Inhaled Corticosteroids for Control of Acute Asthma Exacerbations and Improved Outcomes; A Randomized Controlled Trial E. W. Skorpinski1,2, E. Yousef1,2, S. J. McGeady1,2; 1Division of Allergy/Immunology, A.I. duPont Hospital for Children, Wilmington, DE, 2Thomas Jefferson University, Philadelphia, PA. RATIONALE: To investigate the effectiveness of inhaled corticosteroids (ICS) in controlling acute asthma exacerbations in children at home. Previous studies regarding the efficacy of increased ICS in these instances have provided conflicting results. METHODS: Data was collected on asthmatic children, aged 2 to 17 years, who have been maintained on ICS for at least 3 months. Fifty-seven children were randomized to twice (2X), 4X and 8X maintenance ICS sick-day protocols, and were provided written instructions to contact our office and initiate therapy within 72 hours of onset of increased symptoms. Physicians, blinded to the patients’ dosing assignments, assessed their clinical status with symptom scores via telephone on the initial day and on days 3, 7 and 14 following the start of therapy. RESULTS: Fifteen patients completed the study. There were no differences in the average rates of improvement, based on symptom scores, between the 2X, 4X and 8X maintenance ICS therapy groups. None of these subjects required systemic corticosteroids (SCS), ED visits or hospitalizations. Two of seven 2X assignees and one of five 4X assignees were taken to their primary physicians’ offices for sick-day evaluations during their trials; however, they did not require further intervention. CONCLUSIONS: Our data indicates that acute asthma exacerbations in children can be controlled at home with increased doses of ICS. This intervention may reduce the need for SCS, but a larger patient sample is needed to clarify the role of greater vs. lesser dose increases in ICS in the home management of these exacerbations.
363
Effect of Once-Daily Evening Administration of Low-Dose Mometasone Furoate on Peak Expiratory Flow in Subjects With Mild-to-Moderate Persistent Asthma B. Prenner1, R. Yao2, B. N. Lutsky2; 1Allergy Associates Medical Group, Inc., San Diego, CA, 2Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: The ability of inhaled corticosteroid (ICS) therapy to improve peak expiratory flow (PEF) throughout the day is an important measure of asthma control. It was decided to analyze the effects on PEF measurements observed with once-daily evening (QD PM) dosing of mometasone furoate dry powder inhaler (MF-DPI) in different populations of asthma patients. METHODS: Two randomized, double-blind studies evaluated treatment with MF-DPI 220 mcg QD PM (n = 177) or placebo (n = 178) in 12 weeks of therapy for persistent asthma. Subjects in one study were ICS-naïve. Subjects in the other study were previously maintained on daily ICS therapy (75% were using fluticasone propionate), and completed a pre-baseline ICS reduction period. As a result, subjects in both studies were comparable at baseline with respect to lung function and were pooled for analysis. The analysis compared MF-DPI with placebo for changes from baseline in AM and PM PEF at endpoint. RESULTS: Treatment with MF-DPI 200 QD PM significantly improved AM and PM PEF. The mean change from baseline in AM PEF at endpoint was 28.01 L/min in the MF-DPI group, compared with 3.12 L/min in the placebo group (p < 0.0001). For PM PEF, the mean change from baseline was 21.06 L/min with MF-DPI, and 5.92 with placebo (p = 0.0022). CONCLUSIONS: Treatment with MF-DPI 220 mcg QD PM significantly improved both AM and PM PEF in patients with persistent asthma who were either ICS-naïve or previously maintained on daily ICS therapy. Funding: Schering-Plough Research Institute
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macrophages, lymphocytes, eosinophils and neutrophils and inflammatory mediators. There were no significant differences in basement membrane thickness between FSC and FP250 (95% CI: -2.11, 0.63) or FP100 and FP100+MON (95% CI: -1.97, 0.99). CONCLUSIONS: FSC allowed a 60% reduction in ICS dose while maintaining control of underlying airway inflammation; confirming that treatment with low dose ICS+LABA is as effective as higher dose ICS. However, the addition of montelukast to FP100 offered no additional benefit on control of airway inflammation compared with FP100 alone. (SAS40026/FPD40014) Funding: GlaxoSmithKline
J ALLERGY CLIN IMMUNOL VOLUME 117, NUMBER 2
Budesonide and Montelukast Once Daily Inhibits ExerciseInduced Bronchoconstriction in 6- to 18-Year-Old Children with Asthma T. Grzelewski, J. Jerzynska, I. Stelmach; Department of Pediatrics and Allergy, Medical University of Lodz, M Curie Hospital, Zgierz, POLAND. RATIONALE: To determine whether budesonide and montelukast attenuate exercise-induced bronchoconstriction (EIB) in 6- to 18-year-old children with asthma. METHODS: Randomized, double blind, placebo controlled, single center trial. Children (n = 25) with forced expiratory volume in 1 second (FEV1) 70% of the predicted value and a fall in FEV1 20% after exercise on 2 occasions. Patients received budesonide 200 g/dose one puff and montelukast 5 mg tablets in children aged 6-14 or 10 mg tablets in children over 14 years old (n=12) or placebo (n=13) once daily for 4 weeks. Standardized exercise challenges were performed 24 hours after the last dose. End points included area above the postexercise percent fall in FEV1 versus time curve (AAC0-20min), maximum percent fall in FEV1 from pre-exercise baseline, and time to recovery of FEV1 to within 5% of pre-exercise baseline. RESULTS: Budesonide and montelukast significantly reduced AAC0-20min ( 171 vs 610 % x min for budesonide with montelukast and placebo, respectively, P < 0.05 ) and the maximum percent fall (11% vs 36% for budesonide with montelukast and placebo, respectively, P < 0.05). Budesonide and montelukast treatment resulted in a shorter time to recovery (6 vs 19 minutes for budesonide with montelukast and placebo, respectively, P <0.05 ). CONCLUSIONS: Budesonide and montelukast attenuate EIB in 6- to 18-year-old children with asthma.
361
Treatment of Inhaled Corticosteroid and Leukotriene Receptor Antagonistin Korean Young Cough-Variant Asthma Children J. Jung1, J. Lee2, J. Kim3; 1Dong-A University Hospital, Busan, REPUBLIC OF KOREA, 2Masan Samsung Hospital, Masan, REPUBLIC OF KOREA, 3Ulsa University Hospital, Ulsan, REPUBLIC OF KOREA. RATIONALE: Cough-variant asthma (CVA) is a common cause of chronic cough in young children. Some children who have CVA eventually become classic asthma. We evaluated the effect of inhaled corticosteroid and leukotriene receptor antagonist in young children who are suspected as CVA. METHODS: Forty cough-variant asthma patients who were younger than 5-years-old were enrolled in study. Fifteen were treated with pulmicort nebulization (500g, bid) for 4 weeks (Group A). Fourteen were treated with leukotriene receptor antagonist (Singulair, 4mg) for 4 weeks (Group B). Eleven were treated with intermittent short-acting 2-agonist nebulization (control). We evaluated the mean change of symptom score in night cough and sleep disturbance. RESULTS: There were no differences in age, sex, total IgE, total eosinophil count, duration of cough among 3 groups. Group A and B showed significant improvement of night cough and sleep disturbance after treatment. (p<0.05) In Group A and B, night cough was significantly improved after treatment more than in control. (P<0.05) But the improvement of sleep disturbance didn’t have no signigicant differences between three groups. (P=1.0) CONCLUSIONS: Inhaled corticosteroid and leukotriene receptor antagonist are effective to control of chronic cough in CVA children who are younger than 5-years-old.
362
Early Intervention with High-Dose Inhaled Corticosteroids for Control of Acute Asthma Exacerbations and Improved Outcomes; A Randomized Controlled Trial E. W. Skorpinski1,2, E. Yousef1,2, S. J. McGeady1,2; 1Division of Allergy/Immunology, A.I. duPont Hospital for Children, Wilmington, DE, 2Thomas Jefferson University, Philadelphia, PA. RATIONALE: To investigate the effectiveness of inhaled corticosteroids (ICS) in controlling acute asthma exacerbations in children at home. Previous studies regarding the efficacy of increased ICS in these instances have provided conflicting results. METHODS: Data was collected on asthmatic children, aged 2 to 17 years, who have been maintained on ICS for at least 3 months. Fifty-seven children were randomized to twice (2X), 4X and 8X maintenance ICS sick-day protocols, and were provided written instructions to contact our office and initiate therapy within 72 hours of onset of increased symptoms. Physicians, blinded to the patients’ dosing assignments, assessed their clinical status with symptom scores via telephone on the initial day and on days 3, 7 and 14 following the start of therapy. RESULTS: Fifteen patients completed the study. There were no differences in the average rates of improvement, based on symptom scores, between the 2X, 4X and 8X maintenance ICS therapy groups. None of these subjects required systemic corticosteroids (SCS), ED visits or hospitalizations. Two of seven 2X assignees and one of five 4X assignees were taken to their primary physicians’ offices for sick-day evaluations during their trials; however, they did not require further intervention. CONCLUSIONS: Our data indicates that acute asthma exacerbations in children can be controlled at home with increased doses of ICS. This intervention may reduce the need for SCS, but a larger patient sample is needed to clarify the role of greater vs. lesser dose increases in ICS in the home management of these exacerbations.
363
Effect of Once-Daily Evening Administration of Low-Dose Mometasone Furoate on Peak Expiratory Flow in Subjects With Mild-to-Moderate Persistent Asthma B. Prenner1, R. Yao2, B. N. Lutsky2; 1Allergy Associates Medical Group, Inc., San Diego, CA, 2Schering-Plough Research Institute, Kenilworth, NJ. RATIONALE: The ability of inhaled corticosteroid (ICS) therapy to improve peak expiratory flow (PEF) throughout the day is an important measure of asthma control. It was decided to analyze the effects on PEF measurements observed with once-daily evening (QD PM) dosing of mometasone furoate dry powder inhaler (MF-DPI) in different populations of asthma patients. METHODS: Two randomized, double-blind studies evaluated treatment with MF-DPI 220 mcg QD PM (n = 177) or placebo (n = 178) in 12 weeks of therapy for persistent asthma. Subjects in one study were ICS-naïve. Subjects in the other study were previously maintained on daily ICS therapy (75% were using fluticasone propionate), and completed a pre-baseline ICS reduction period. As a result, subjects in both studies were comparable at baseline with respect to lung function and were pooled for analysis. The analysis compared MF-DPI with placebo for changes from baseline in AM and PM PEF at endpoint. RESULTS: Treatment with MF-DPI 200 QD PM significantly improved AM and PM PEF. The mean change from baseline in AM PEF at endpoint was 28.01 L/min in the MF-DPI group, compared with 3.12 L/min in the placebo group (p < 0.0001). For PM PEF, the mean change from baseline was 21.06 L/min with MF-DPI, and 5.92 with placebo (p = 0.0022). CONCLUSIONS: Treatment with MF-DPI 220 mcg QD PM significantly improved both AM and PM PEF in patients with persistent asthma who were either ICS-naïve or previously maintained on daily ICS therapy. Funding: Schering-Plough Research Institute
364
SUNDAY
macrophages, lymphocytes, eosinophils and neutrophils and inflammatory mediators. There were no significant differences in basement membrane thickness between FSC and FP250 (95% CI: -2.11, 0.63) or FP100 and FP100+MON (95% CI: -1.97, 0.99). CONCLUSIONS: FSC allowed a 60% reduction in ICS dose while maintaining control of underlying airway inflammation; confirming that treatment with low dose ICS+LABA is as effective as higher dose ICS. However, the addition of montelukast to FP100 offered no additional benefit on control of airway inflammation compared with FP100 alone. (SAS40026/FPD40014) Funding: GlaxoSmithKline