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Stanley J. Szefler - One of the best experts on this subject based on the ideXlab platform.
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Acetaminophen versus Ibuprofen in Young Children with Mild Persistent Asthma
The New England journal of medicine, 2016Co-Authors: William J. Sheehan, Stanley J. Szefler, Susan J Boehmer, David T Mauger, Ian M. Paul, James N. Moy, Anne M. Fitzpatrick, D. J. Jackson, Leonard B. Bacharier, Michael D. CabanaAbstract:BackgroundStudies have suggested an association between frequent acetaminophen use and Asthma-related complications among children, leading some physicians to recommend that acetaminophen be avoided in children with Asthma; however, appropriately designed trials evaluating this association in children are lacking. MethodsIn a multicenter, prospective, randomized, double-blind, parallel-group trial, we enrolled 300 children (age range, 12 to 59 months) with Mild Persistent Asthma and assigned them to receive either acetaminophen or ibuprofen when needed for the alleviation of fever or pain over the course of 48 weeks. The primary outcome was the number of Asthma exacerbations that led to treatment with systemic glucocorticoids. Children in both groups received standardized Asthma-controller therapies that were used in a simultaneous, factorially linked trial. ResultsParticipants received a median of 5.5 doses (interquartile range, 1.0 to 15.0) of trial medication; there was no significant between-group dif...
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markers of differential response to inhaled corticosteroid treatment among children with Mild Persistent Asthma
The Journal of Allergy and Clinical Immunology: In Practice, 2015Co-Authors: Joe K Gerald, Stanley J. Szefler, Lynn B Gerald, Monica M Vasquez, Wayne J Morgan, Susan J Boehmer, Robert F Lemanske, David T Mauger, Robert C Strunk, Robert S. ZeigerAbstract:Background Inhaled corticosteroids are recommended as first-line therapy for children with Mild Persistent Asthma; however, specific patient characteristics may modify the treatment response. Objective Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. Methods Children aged 6 to 18 years with Mild Persistent Asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of Asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. Results Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by Asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in Asthma control. Conclusions Children with Mild Persistent Asthma who have markers of atopic Asthma or who have greater Asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy.
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Markers of Differential Response to Inhaled Corticosteroid Treatment Among Children with Mild Persistent Asthma.
The journal of allergy and clinical immunology. In practice, 2015Co-Authors: Joe K Gerald, Stanley J. Szefler, Lynn B Gerald, Monica M Vasquez, Wayne J Morgan, Susan J Boehmer, Robert F Lemanske, David T Mauger, Robert C Strunk, Robert S. ZeigerAbstract:Inhaled corticosteroids are recommended as first-line therapy for children with Mild Persistent Asthma; however, specific patient characteristics may modify the treatment response. Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. Children aged 6 to 18 years with Mild Persistent Asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of Asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by Asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in Asthma control. Children with Mild Persistent Asthma who have markers of atopic Asthma or who have greater Asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with Mild Persistent Asthma
The Journal of Allergy and Clinical Immunology: In Practice, 2013Co-Authors: Larsgoran Carlsson, Stanley J. Szefler, Tom Uryniak, James W. BakerAbstract:Background Budesonide inhalation suspension (BIS) and montelukast provide acceptable Asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with Mild Persistent Asthma. Objective We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with Asthma. Methods Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with Mild Asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for Mild or severe Asthma worsening, respectively. Primary efficacy assessment was time to first additional Asthma medication for exacerbation over 52 weeks. Results Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional Asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms ( P = .026). Both treatments were well tolerated. Conclusion BIS and montelukast provided acceptable Asthma control in children aged 2 to 4 years with Mild Persistent Asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast.
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Budesonide Inhalation Suspension Versus Montelukast in Children Aged 2 to 4 Years with Mild Persistent Asthma
The journal of allergy and clinical immunology. In practice, 2012Co-Authors: Stanley J. Szefler, Larsgoran Carlsson, Tom Uryniak, James W. BakerAbstract:Budesonide inhalation suspension (BIS) and montelukast provide acceptable Asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with Mild Persistent Asthma. We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with Asthma. Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with Mild Asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for Mild or severe Asthma worsening, respectively. Primary efficacy assessment was time to first additional Asthma medication for exacerbation over 52 weeks. Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional Asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms (P = .026). Both treatments were well tolerated. BIS and montelukast provided acceptable Asthma control in children aged 2 to 4 years with Mild Persistent Asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
James W. Baker - One of the best experts on this subject based on the ideXlab platform.
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budesonide inhalation suspension versus montelukast in children aged 2 to 4 years with Mild Persistent Asthma
The Journal of Allergy and Clinical Immunology: In Practice, 2013Co-Authors: Larsgoran Carlsson, Stanley J. Szefler, Tom Uryniak, James W. BakerAbstract:Background Budesonide inhalation suspension (BIS) and montelukast provide acceptable Asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with Mild Persistent Asthma. Objective We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with Asthma. Methods Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with Mild Asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for Mild or severe Asthma worsening, respectively. Primary efficacy assessment was time to first additional Asthma medication for exacerbation over 52 weeks. Results Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional Asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms ( P = .026). Both treatments were well tolerated. Conclusion BIS and montelukast provided acceptable Asthma control in children aged 2 to 4 years with Mild Persistent Asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast.
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Budesonide Inhalation Suspension Versus Montelukast in Children Aged 2 to 4 Years with Mild Persistent Asthma
The journal of allergy and clinical immunology. In practice, 2012Co-Authors: Stanley J. Szefler, Larsgoran Carlsson, Tom Uryniak, James W. BakerAbstract:Budesonide inhalation suspension (BIS) and montelukast provide acceptable Asthma control, whereas overall measures favored BIS in children aged 2 to 8 years with Mild Persistent Asthma. We compared BIS and montelukast over a 1-year period in children aged 2 to 4 years with Asthma. Data were derived from a 52-week, open-label, randomized, active-controlled, multicenter study (NCT00641472). Children with Mild Asthma received either BIS 0.5 mg or montelukast 4 to 5 mg once daily. Patients were stepped up to twice-daily BIS or oral corticosteroids for Mild or severe Asthma worsening, respectively. Primary efficacy assessment was time to first additional Asthma medication for exacerbation over 52 weeks. Two hundred two patients, age 2 to 4 years, received BIS (n = 105) or montelukast (n = 97). No difference was observed between the BIS and montelukast groups in median time to first additional Asthma medication over 52 weeks (183 vs 86 days). Statistically significant differences were observed in favor of BIS over montelukast in the percentage of patients requiring oral steroids at 52 weeks (21.9% vs 37.1%; P = .022), the rate (number/patient/year) of additional courses of medication (1.35 vs 2.30; P = .003), the rate of additional oral steroid therapy (0.44 vs 0.88; P = .008), and caregivers' ability to manage the patient's symptoms (P = .026). Both treatments were well tolerated. BIS and montelukast provided acceptable Asthma control in children aged 2 to 4 years with Mild Persistent Asthma with no significant difference between treatments in the primary end point; however, several secondary outcomes showed statistically significant differences (and many had numerical differences) in favor of BIS over montelukast. Copyright © 2012 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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variability of symptoms in Mild Persistent Asthma baseline data from the miami study
Respiratory Medicine, 2004Co-Authors: Robert S. Zeiger, James W. Baker, Michael S. Kaplan, David S. Pearlman, Michael Schatz, Steven R. Bird, Carolyn M. Hustad, Jonathan M. EdelmanAbstract:Abstract Objective : To describe the variability of the Asthma phenotype in patients with Mild Persistent Asthma enrolled in the Mild Asthma Montelukast versus Inhaled Corticosteroid (MIAMI) study. Methods : The variability of Asthma rescue-free days, Asthma symptoms, albuterol use, medical resource use, and exercise limitations among patients with documented Mild Persistent Asthma was compared between the month before study enrollment and the last 2 weeks of the run-in period. Results : Patients eligible for randomization ( n =400), aged 15–85 years, exhibited symptoms (mean±sd) 3.6±1.3days/week, β -agonist use 3.5±1.3 days/week, and normal FEV 1 (94.0±9.9% predicted) during the last 2 weeks of the run-in period. In the year before enrollment, medical intervention for Asthma flares was common: 38.5% made office visits, 15.8% had oral corticosteroids, and 8.3% required emergency room or hospitalized care. In the month before enrollment, 11.8% experienced daily symptoms, and 28.3% had limitations of normal activity. Patients with daily symptoms in the month before study enrollment, compared with those having less-than-daily symptoms, experienced fewer rescue-free days ( P =0.024) and had more days per week with symptoms ( P =0.008) and requiring albuterol ( P =0.048) during the run-in; FEV 1 was similar for both groups (93.1% vs. 94.2% predicted, respectively). Conclusion : Patients with Mild Persistent Asthma reported a substantial disease burden in the year before enrollment. The Asthma burden experienced by these patients both before and during the run-in period was of sufficient severity to support the recommendation that Mild Persistent Asthma should be managed with daily controller therapy.
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Variability of symptoms in Mild Persistent Asthma: baseline data from the MIAMI study.
Respiratory medicine, 2004Co-Authors: Robert S. Zeiger, James W. Baker, Michael S. Kaplan, David S. Pearlman, Michael Schatz, Steven R. Bird, Carolyn M. Hustad, Jonathan M. EdelmanAbstract:To describe the variability of the Asthma phenotype in patients with Mild Persistent Asthma enrolled in the Mild Asthma Montelukast versus Inhaled Corticosteroid (MIAMI) study. The variability of Asthma rescue-free days, Asthma symptoms, albuterol use, medical resource use, and exercise Limitations among patients with documented Mild Persistent Asthma was compared between the month before study enrollment and the last 2 weeks of the run-in period. Patients eligible for randomization (n = 400), aged 15-85 years, exhibited symptoms (mean +/- SD) 3.6 +/- 1.3 days/week, beta-agonist use 3.5 +/- 1.3 days/week, and normal FEV1 (94.0 +/- 9.9% predicted) during the last 2 weeks of the run-in period. In the year before enrollment, medical intervention for Asthma flares was common: 38.5% made office visits, 15.8% had oral corticosteroids, and 8.3% required emergency room or hospitalized care. In the month before enrollment, 11.8% experienced daily symptoms, and 28.3% had limitations of normal activity. Patients with daily symptoms in the month before study enrollment, compared with those having less-than-daily symptoms, experienced fewer rescue-free days (P = 0.024) and had more days per week with symptoms (P = 0.008) and requiring albuterol (P = 0.048) during the run-in; FEV1 was similar for both groups (93.1% vs. 94.2% predicted, respectively). Patients with Mild Persistent Asthma reported a substantial disease burden in the year before enrollment. The Asthma burden experienced by these patients both before and during the run-in period was of sufficient severity to support the recommendation that Mild Persistent Asthma should be managed with daily controller therapy.
Gustavo J. Rodrigo - One of the best experts on this subject based on the ideXlab platform.
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daily versus intermittent inhaled corticosteroid treatment for Mild Persistent Asthma
Current Opinion in Allergy and Clinical Immunology, 2014Co-Authors: Gustavo J. RodrigoAbstract:PURPOSE OF REVIEW Guidelines recommend the use of daily inhaled corticosteroids as preferred treatment for preschoolers, children, adolescents, and adults with recurrent wheezing and Mild Persistent Asthma. However, intermittent or as-needed inhaled corticosteroids treatment in response to symptoms is an emerging strategy. This review is focused on the analysis (clinical efficacy and safety) of this approach in comparison with the current daily-based therapy. RECENT FINDINGS Recently, some authors favored the use of inhaled corticosteroids based on symptoms. It has been suggested that a symptom-based approach could reduce the amount of drug used, minimize the risk of adverse events, and reduce healthcare costs. In contrast, physicians prescribing intermittent inhaled corticosteroids would give the wrong message to their patients about the chronicity of the disease. Currently, there is a significant body of high-quality clinical studies and systematic reviews that have addressed this important controversy, and whose analysis allows us to extract some important conclusions. SUMMARY Present evidence does not support a change in the direction of an intermittent or symptom-based use approach for recurrent wheezing and Mild-to-moderate Persistent Asthma. At this point, there is no convincing basis to alter the current strategy to inhaled corticosteroids dosing, and more studies are needed comparing these two approaches.
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Daily versus intermittent inhaled corticosteroid treatment for Mild Persistent Asthma.
Current opinion in allergy and clinical immunology, 2014Co-Authors: Gustavo J. RodrigoAbstract:Guidelines recommend the use of daily inhaled corticosteroids as preferred treatment for preschoolers, children, adolescents, and adults with recurrent wheezing and Mild Persistent Asthma. However, intermittent or as-needed inhaled corticosteroids treatment in response to symptoms is an emerging strategy. This review is focused on the analysis (clinical efficacy and safety) of this approach in comparison with the current daily-based therapy. Recently, some authors favored the use of inhaled corticosteroids based on symptoms. It has been suggested that a symptom-based approach could reduce the amount of drug used, minimize the risk of adverse events, and reduce healthcare costs. In contrast, physicians prescribing intermittent inhaled corticosteroids would give the wrong message to their patients about the chronicity of the disease. Currently, there is a significant body of high-quality clinical studies and systematic reviews that have addressed this important controversy, and whose analysis allows us to extract some important conclusions. Present evidence does not support a change in the direction of an intermittent or symptom-based use approach for recurrent wheezing and Mild-to-moderate Persistent Asthma. At this point, there is no convincing basis to alter the current strategy to inhaled corticosteroids dosing, and more studies are needed comparing these two approaches.
Elham Mohamed Mostafa - One of the best experts on this subject based on the ideXlab platform.
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Effect of different monotherapies on serum nitric oxide and pulmonary functions in children with Mild Persistent Asthma.
Archives of medical science : AMS, 2010Co-Authors: Zeinab Mohamed Radwan, Gamal Yamamah, Hala Hamdy Shaaban, Azza Mohamed Omar Abdel-rahman, Amany Abdel-ghany Ismaeil, Elham Mohamed MostafaAbstract:Common medications used to treat Mild Persistent Asthma are glucocorticoids, leukotriene receptor antagonists and theophylline. The aim of the study was to evaluate monotherapy with either inhaled steroids, oral leukotriene receptor antagonist or theophylline in Egyptian children with Mild Persistent Asthma by determining their clinical, laboratory and spirometric responses to treatment. Thirty-nine Mild Asthmatic children between 8 and 13 years of age were included in the study. Patients were classified according to therapy received into four groups: oral leukotriene receptor antagonist (montelukast), inhaled corticosteroid (fluticasone propionate), sustained-release (SR) theophylline, and no treatment. Pulmonary function testing was performed at the start of therapy and 8 weeks later using spirometry. Eosinophil count and serum nitric oxide were estimated in the blood. Minitab statistical package was used for analysis of data. Follow-up after 8 weeks revealed significant improvement in FEV1% in groups 1 (p < 0.01) and 3 (p < 0.05), significant improvement in PEFR in groups 1 (p < 0.05) and 2 (p < 0.01), significant decline in serum NO levels in groups 1 (p < 0.05) and 2 (p < 0.05), as well as significant improvement in eosinophil count in groups 1, 2 and 3 (p < 0.01, < 0.001, < 0.01 respectively). There was a statistically significant positive correlation between the decline in serum NO and the decline in blood eosinophil % in group 2 (p < 0.05). Inhaled corticosteroids and montelukast have a significant role in controlling the pulmonary functions and the inflammatory process in children with Mild Persistent Asthma, although inhaled corticosteroids seem to yield a better response. Children with Mild Persistent Asthma should receive a controller medication, and SR theophylline may be a good cost-benefit alternative for low socio-economic groups of patients.
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effect of different monotherapies on serum nitric oxide and pulmonary functions in children with Mild Persistent Asthma
Archives of Medical Science, 2010Co-Authors: Azza Mohamed Omar Abdelrahman, Zeinab Mohamed Radwan, Gamal Yamamah, Hala Hamdy Shaaban, Amany Abdel-ghany Ismaeil, Elham Mohamed MostafaAbstract:Introduction: Common medications used to treat Mild Persistent Asthma are glucocorticoids, leukotriene receptor antagonists and theophylline. The aim of the study was to evaluate monotherapy with either inhaled steroids, oral leukotriene receptor antagonist or theophylline in Egyptian children with Mild Persistent Asthma by determining their clinical, laboratory and spirometric responses to treatment. Material and methods: Thirty-nine Mild Asthmatic children between 8 and 13 years of age were included in the study. Patients were classified according to therapy received into four groups: oral leukotriene receptor antagonist (montelukast), inhaled corticosteroid (fluticasone propionate), sustained-release (SR) theophylline, and no treatment. Pulmonary function testing was performed at the start of therapy and 8 weeks later using spirometry. Eosinophil count and serum nitric oxide were estimated in the blood. Minitab statistical package was used for analysis of data. Results: Follow-up after 8 weeks revealed significant improvement in FEV1% in groups 1 (p < 0.01) and 3 (p < 0.05), significant improvement in PEFR in groups 1 (p < 0.05) and 2 (p < 0.01), significant decline in serum NO levels in groups 1 (p < 0.05) and 2 (p < 0.05), as well as significant improvement in eosinophil count in groups 1, 2 and 3 (p < 0.01, < 0.001, < 0.01 respectively). There was a statistically significant positive correlation between the decline in serum NO and the decline in blood eosinophil % in group 2 (p < 0.05). Conclusions: Inhaled corticosteroids and montelukast have a significant role in controlling the pulmonary functions and the inflammatory process in children with Mild Persistent Asthma, although inhaled corticosteroids seem to yield a better response. Children with Mild Persistent Asthma should receive a controller medication, and SR theophylline may be a good cost-benefit alternative for low socio-economic groups of patients.
Robert S. Zeiger - One of the best experts on this subject based on the ideXlab platform.
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markers of differential response to inhaled corticosteroid treatment among children with Mild Persistent Asthma
The Journal of Allergy and Clinical Immunology: In Practice, 2015Co-Authors: Joe K Gerald, Stanley J. Szefler, Lynn B Gerald, Monica M Vasquez, Wayne J Morgan, Susan J Boehmer, Robert F Lemanske, David T Mauger, Robert C Strunk, Robert S. ZeigerAbstract:Background Inhaled corticosteroids are recommended as first-line therapy for children with Mild Persistent Asthma; however, specific patient characteristics may modify the treatment response. Objective Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. Methods Children aged 6 to 18 years with Mild Persistent Asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of Asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. Results Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by Asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in Asthma control. Conclusions Children with Mild Persistent Asthma who have markers of atopic Asthma or who have greater Asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy.
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Markers of Differential Response to Inhaled Corticosteroid Treatment Among Children with Mild Persistent Asthma.
The journal of allergy and clinical immunology. In practice, 2015Co-Authors: Joe K Gerald, Stanley J. Szefler, Lynn B Gerald, Monica M Vasquez, Wayne J Morgan, Susan J Boehmer, Robert F Lemanske, David T Mauger, Robert C Strunk, Robert S. ZeigerAbstract:Inhaled corticosteroids are recommended as first-line therapy for children with Mild Persistent Asthma; however, specific patient characteristics may modify the treatment response. Identify demographic, clinical, and atopic characteristics that may modify the inhaled corticosteroid treatment response among children enrolled in the Treating Children to Prevent Exacerbations of Asthma trial. Children aged 6 to 18 years with Mild Persistent Asthma were randomized to 44 weeks of combined, daily, rescue, or placebo treatment. Daily treatment consisted of 40 μg of beclomethasone twice daily. Rescue treatment consisted of 40 μg of beclomethasone accompanying each symptom-driven albuterol actuation. Combined treatment consisted of both. Outcomes included time to first exacerbation and proportion of Asthma control days. Fourteen baseline characteristics were selected for interaction testing on the basis of their clinical relevance. Two hundred eighty-eight children were randomized. Seventy-five percent were white, and 55% were male. As measured by time to first exacerbation, 4 characteristics identified children who received greater benefit from treatment: non-Hispanic ethnicity, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and history of oral corticosteroid use in the year before enrollment. As measured by Asthma control days, 4 characteristics identified children who received greater benefit from treatment: male sex, positive aeroallergen skin test result, serum immunoglobulin E level of 350 K/μL or more, and incomplete run-in Asthma control. Children with Mild Persistent Asthma who have markers of atopic Asthma or who have greater Asthma burden may obtain greater benefit from beclomethasone therapy. Additional study is needed to confirm whether these markers can guide individualized therapy. Copyright © 2015 American Academy of Allergy, Asthma & Immunology. Published by Elsevier Inc. All rights reserved.
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Use of beclomethasone dipropionate as rescue treatment for children with Mild Persistent Asthma (TREXA): a randomised, double-blind, placebo-controlled trial
Lancet (London England), 2011Co-Authors: Fernando D. Martinez, Stanley J. Szefler, Vernon M Chinchilli, Robert S. Zeiger, Wayne J Morgan, Susan J Boehmer, Robert F Lemanske, David T Mauger, Robert C Strunk, Leonard B. BacharierAbstract:Summary Background Daily inhaled corticosteroids are an effective treatment for Mild Persistent Asthma, but some children have exacerbations even with good day-to-day control, and many discontinue treatment after becoming asymptomatic. We assessed the effectiveness of an inhaled corticosteroid (beclomethasone dipropionate) used as rescue treatment. Methods In this 44-week, randomised, double-blind, placebo-controlled trial we enrolled children and adolescents with Mild Persistent Asthma aged 5–18 years from five clinical centres in the USA. A computer-generated randomisation sequence, stratified by clinical centre and age group, was used to randomly assign participants to one of four treatment groups: twice daily beclomethasone with beclomethasone plus albuterol as rescue (combined group); twice daily beclomethasone with placebo plus albuterol as rescue (daily beclomethasone group); twice daily placebo with beclomethasone plus albuterol as rescue (rescue beclomethasone group); and twice daily placebo with placebo plus albuterol as rescue (placebo group). Twice daily beclomethasone treatment was one puff of beclomethasone (40 μg per puff) or placebo given in the morning and evening. Rescue beclomethasone treatment was two puffs of beclomethasone or placebo for each two puffs of albuterol (180 μg) needed for symptom relief. The primary outcome was time to first exacerbation that required oral corticosteroids. A secondary outcome measured linear growth. Analysis was by intention to treat. This study is registered with clinicaltrials.gov, number NCT00394329. Results 843 children and adolescents were enrolled into this trial, of whom 288 were assigned to one of four treatment groups; combined (n=71), daily beclomethasone (n=72), rescue beclomethasone (n=71), and placebo (n=74)—555 individuals were excluded during the run-in, according to predefined criteria. Compared with the placebo group (49%, 95% CI 37–61), the frequency of exacerbations was lower in the daily (28%, 18–40, p=0·03), combined (31%, 21–43, p=0·07), and rescue (35%, 24–47, p=0·07) groups. Frequency of treatment failure was 23% (95% CI 14–43) in the placebo group, compared with 5·6% (1·6–14) in the combined (p=0·012), 2·8% (0–10) in the daily (p=0·009), and 8·5% (2–15) in the rescue (p=0·024) groups. Compared with the placebo group, linear growth was 1·1 cm (SD 0·3) less in the combined and daily arms (p Interpretation Children with Mild Persistent Asthma should not be treated with rescue albuterol alone and the most effective treatment to prevent exacerbations is daily inhaled corticosteroids. Inhaled corticosteroids as rescue medication with albuterol might be an effective step-down strategy for children with well controlled, Mild Asthma because it is more effective at reducing exacerbations than is use of rescue albuterol alone. Use of daily inhaled corticosteroid treatment and related side-effects such as growth impairment can therefore be avoided. Funding National Heart, Lung and Blood Institute.
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Short-term and long-term Asthma control in patients with Mild Persistent Asthma receiving montelukast or fluticasone: a randomized controlled trial
The American journal of medicine, 2005Co-Authors: E. John Orav, Robert S. Zeiger, Michael S. Kaplan, David S. Pearlman, Michael Schatz, Steven R. Bird, Carolyn M. Hustad, Jonathan M. EdelmanAbstract:Abstract Purpose To determine whether montelukast is as effective as fluticasone in controlling Mild Persistent Asthma as determined by rescue-free days. Subjects and methods Participants aged 15 to 85 years with Mild Persistent Asthma (n = 400) were randomized to oral montelukast (10 mg once nightly) or inhaled fluticasone (88 μg twice daily) in a year-long, parallel-group, multicenter study with a 12-week, double-blind period, followed by a 36-week, open-label period. Results The mean percentage of rescue-free days was similar between treatments after 12 weeks (fluticasone: 74.9%, montelukast: 73.1%; difference=1.8%, 95% confidence interval [CI]: −3.2% to 6.8%) but not during the open-label period (fluticasone: 77.3%, montelukast: 71.1%; difference=6.2%, 95% CI: 0.8% to 11.7%). Although both fluticasone and montelukast significantly improved symptoms, quality of life, and symptom-free days during both treatment periods, greater improvements occurred with fluticasone in lung function during both periods and in Asthma control during open-label treatment. Post hoc analyses revealed a difference in rescue-free days favoring fluticasone in participants in the quartiles for lowest lung function and greatest albuterol use at baseline. Conclusion In patients with Mild Persistent Asthma, rescue-free days and most Asthma control measures improved similarly with fluticasone or montelukast over the short term, but with prolonged open-label treatment, Asthma control improved more with fluticasone. Improved Asthma control with fluticasone appeared to occur in those with decreased lung function and greater albuterol use at baseline. In the remaining patients, the two treatments appeared to be comparable. These results suggest that classification criteria for Mild Persistent Asthma may need to be re-evaluated.
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variability of symptoms in Mild Persistent Asthma baseline data from the miami study
Respiratory Medicine, 2004Co-Authors: Robert S. Zeiger, James W. Baker, Michael S. Kaplan, David S. Pearlman, Michael Schatz, Steven R. Bird, Carolyn M. Hustad, Jonathan M. EdelmanAbstract:Abstract Objective : To describe the variability of the Asthma phenotype in patients with Mild Persistent Asthma enrolled in the Mild Asthma Montelukast versus Inhaled Corticosteroid (MIAMI) study. Methods : The variability of Asthma rescue-free days, Asthma symptoms, albuterol use, medical resource use, and exercise limitations among patients with documented Mild Persistent Asthma was compared between the month before study enrollment and the last 2 weeks of the run-in period. Results : Patients eligible for randomization ( n =400), aged 15–85 years, exhibited symptoms (mean±sd) 3.6±1.3days/week, β -agonist use 3.5±1.3 days/week, and normal FEV 1 (94.0±9.9% predicted) during the last 2 weeks of the run-in period. In the year before enrollment, medical intervention for Asthma flares was common: 38.5% made office visits, 15.8% had oral corticosteroids, and 8.3% required emergency room or hospitalized care. In the month before enrollment, 11.8% experienced daily symptoms, and 28.3% had limitations of normal activity. Patients with daily symptoms in the month before study enrollment, compared with those having less-than-daily symptoms, experienced fewer rescue-free days ( P =0.024) and had more days per week with symptoms ( P =0.008) and requiring albuterol ( P =0.048) during the run-in; FEV 1 was similar for both groups (93.1% vs. 94.2% predicted, respectively). Conclusion : Patients with Mild Persistent Asthma reported a substantial disease burden in the year before enrollment. The Asthma burden experienced by these patients both before and during the run-in period was of sufficient severity to support the recommendation that Mild Persistent Asthma should be managed with daily controller therapy.