Nebulized Budesonide Inhalation Suspension Compared With Cromolyn Sodium Nebulizer Solution for Asthma in Young Children: Results of a Randomized Outcomes Trial

Leflein, Jeffrey; Szefler, Stanley J.; Murphy, Kevin R.; Fitzpatrick, Sherahe; Cruz-Rivera, Mario; Miller, Christopher J.; Smith, Joseph A.

doi:10.1542/peds.109.5.866

Cited by 74 publications

(49 citation statements)

References 33 publications

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“…Fewer comparative studies have been conducted in children 5 years and younger. However two studies of nearly 1,000 children in this age group 87,88 confirmed the superiority of inhaled glucocorticosteroids over cromones for almost all endpoints assessing asthma control (Evidence A).…”

Section: Inhaled Glucocorticosteroids and Cromolynmentioning

confidence: 96%

Global strategy for the diagnosis and management of asthma in children 5 years and younger

Pedersen

Hurd

Lemanske

et al. 2010

Pediatric Pulmonology

270

207

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Asthma is the most common chronic disease of childhood and the leading cause of childhood morbidity from chronic disease as measured by school absences, emergency department visits, and hospitalions1. During the past two decades, many scientific advances have improved our understanding of asthma and our ability to manage and control it effectively. However, in children 5 years and younger, the clinical symptoms of asthma are variable and non‐specific. Furthermore, neither airflow limitation nor airway inflammation, the main pathologic hallmarks of the condition, can be assessed routinely in this age group. For this reason, to aid in the diagnosis of asthma in young children, a symptoms‐only descriptive approach that includes the definition of various wheezing phenotypes has been recommended2. In 1993, the Global Initiative for Asthma (GINA) was implemented to develop a network of individuals, organizations, and public health officials to disseminate information about the care of patients with asthma while at the same time assuring a mechanism to incorporate the results of scientific investigations into asthma care. Since then, GINA has developed and regularly revised a Global Strategy for Asthma Management and Prevention. Publications based on the Global Strategy for Asthma Management and Prevention have been translated into many different languages to promote international collaboration and dissemination of information.In this report, Global Strategy for Asthma Management and Prevention in Children 5 Years and Younger, an effort has been made to present the special challenges that must be taken into account in managing asthma in children during the first 5 years of life, including difficulties with diagnosis, the efficacy and safety of drugs and drug delivery systems, and the lack of data on new therapies. Approaches to these issues will vary among populations in the world based on socioeconomic conditions, genetic diversity, cultural beliefs, and differences in healthcare access and delivery. Patients in this age group are often managed by pediatricians and general practitioners routinely faced with a wide variety of issues related to childhood diseases. Pediatr Pulmonol. 2011; 46:1–17. © 2010 Wiley‐Liss, Inc.

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Section: Inhaled Glucocorticosteroids and Cromolynmentioning

confidence: 96%

Global strategy for the diagnosis and management of asthma in children 5 years and younger

Pedersen

Hurd

Lemanske

et al. 2010

Pediatric Pulmonology

270

207

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“…34 -36 Efficacy based on the rate of asthma exacerbations, use of additional chronic asthma therapy, asthma symptom scores, and breakthrough medication use by patients in this study has been reported in detail elsewhere. 21 Briefly, compared with cromolyn sodium, treatment with budesonide inhalation suspension resulted in a significantly lower mean rate of asthma exacerbations, significantly longer times to first asthma exacerbation, significantly longer times to first additional use of chronic asthma therapy, and significant improvements in asthma symptom scores and breakthrough medication use (P Յ .001 for all variables). Additionally, children receiving budesonide inhalation suspension experienced more symptom-free days (ie, a day and night with no reported asthma symptoms) and episode-free days (ie, a day and night with no reported asthma symptoms, drug-related adverse events, or breakthrough bronchodilator use) compared with children receiving cromolyn sodium (P ϭ .0001).…”

Section: Discussionmentioning

confidence: 95%

“…37 Safety profiles were similar between the 2 treatments. 21 Both improved asthma control and a simplified dosing regimen with budesonide inhalation suspension compared with cromolyn sodium likely contributed to greater caregiver satisfaction and quality of life with budesonide. Compared with dosing of cromolyn sodium 3 or 4 times daily, the convenience of once-or twice-daily dosing with budesonide inhalation suspension likely decreased caregiver burden and enhanced the willingness of caregivers to comply with administering inhalation therapy to their young children with asthma, further improving treatment effectiveness.…”

Section: Discussionmentioning

confidence: 99%

“…The results showed that budesonide inhalation suspension was as well-tolerated and more effective than nebulized cromolyn sodium based on conventional measures of tolerability, safety, and asthma control (asthma exacerbations, pulmonary function, asthma symptom scores, and breakthrough medication use). 21 In this article we report on the effects of budesonide inhalation suspension compared with cromolyn sodium nebulizer solution on caregiver quality of life and pediatric health status. …”

mentioning

confidence: 99%

“…Study design and treatments have been described in detail previously. 21 Briefly, the study began with a 2-to 3-week baseline phase. Patients with asthma symptom severity scores Ն2 (scale: 0 ϭ no symptoms to 3 ϭ severe symptoms) on at least 7 of 14 days before randomization and who used breakthrough medication on at least 5 of these 14 days were randomized 1:1 to http://www.pediatrics.org/cgi/content/full/112/3/e212 e213 by guest on May 11, 2018 http://pediatrics.aappublications.org/ Downloaded from receive budesonide inhalation suspension 0.5 mg (once daily or in divided doses twice daily per investigator judgment) or cromolyn sodium 20 mg 4 times daily for 8 weeks.…”

mentioning

confidence: 99%

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Effects of Budesonide Inhalation Suspension Compared With Cromolyn Sodium Nebulizer Solution on Health Status and Caregiver Quality of Life in Childhood Asthma

Murphy¹,

Fitzpatrick²,

Cruz-Rivera

et al. 2003

Pediatrics

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ABSTRACT. Objective. To compare the effects of 2 nebulizable controller asthma medications on caregiver and pediatric quality of life.Methods. In this 52-week, randomized trial, children aged 2 to 6 years with mild to moderate persistent asthma received budesonide inhalation suspension 0.5 mg (total daily dose) once or twice daily (n ‫؍‬ 168) or cromolyn sodium nebulizer solution 20 mg 4 times daily (n ‫؍‬ 167) for 8 weeks, with dosage adjustment thereafter at the investigators' discretion. The Pediatric Asthma Caregiver's Quality of Life Questionnaire (PACQLQ), Compliance/Caregiver Satisfaction Questionnaire (CCSQ), Modified Child Health Questionnaire-Parent Form 50 (CHQ-PF50), and Functional Status-II(R) (FS-II[R])Questionnaire were administered at baseline and weeks 8, 28, and 52. Global assessments of ease of asthma management and child health status were obtained from caregivers and physicians at the end of the study.Results. Improvements from baseline in domain-specific (activities and emotional function) and total PAC-QLQ scores were greater at each time point (weeks 8, 28, and 52) for caregivers of patients treated with budesonide compared with caregivers of patients receiving cromolyn sodium. Only the budesonide group met the criterion for a clinically important improvement (>0.5 unit change) in all PACQLQ domains by week 8, which was maintained at weeks 28 and 52. Moreover, improvements surpassed the criterion for moderate clinical importance (1.0 unit change) in all PACQLQ domains for the budesonide group, but this level of improvement was only achieved in the activities domain (at week 28) for the cromolyn sodium group. Based on the CCSQ, budesonide resulted in greater caregiver satisfaction, treatment convenience, ease of use, and compliance compared with cromolyn sodium. Thus, 90.7% of caregivers in the budesonide group were "completely or very satisfied" compared with 53.4% in the cromolyn sodium group. Over half (54.6%) of caregivers in the budesonide group rated budesonide "highly or very convenient" compared with 23% for cromolyn sodium; 77% rated budesonide "extremely or very easy" to use compared with 47% for cromolyn. Adherence with daily medication regimens was reported for 76% of children in the budesonide group compared with 57% in the cromolyn sodium group. Child health status, as indicated by mean FS-II(R) scores, showed improvements from baseline in both groups at weeks 8, 28, and 52. There was a trend for these improvements to be superior in the budesonide group. Additionally, budesonide was superior to cromolyn sodium in caregiver and physician global assessments. At the end of the study, 76% of caregivers of children receiving budesonide reported asthma management to be "a great deal easier" compared with the start of the study, and 74% rated the overall health status of their child as "much better now than 1 year ago." In contrast, only 29% and 37% of caregivers whose children received cromolyn sodium provided these respective ratings.Conclusions. Budesonide inhalation suspension i...

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Long-acting beta2-agonists versus anti-leukotrienes as add-on therapy to inhaled corticosteroids for chronic asthma

Ram

Cates²,

Ducharme

2005

Cochrane Database of Systematic Reviews

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Nebulized Budesonide Inhalation Suspension Compared With Cromolyn Sodium Nebulizer Solution for Asthma in Young Children: Results of a Randomized Outcomes Trial

Abstract: Budesonide inhalation suspension was more effective than nebulized cromolyn sodium in young children with persistent asthma. Both treatments were well tolerated with similar adverse event profiles.

Cited by 74 publications

References 33 publications

Global strategy for the diagnosis and management of asthma in children 5 years and younger

Global strategy for the diagnosis and management of asthma in children 5 years and younger

Effects of Budesonide Inhalation Suspension Compared With Cromolyn Sodium Nebulizer Solution on Health Status and Caregiver Quality of Life in Childhood Asthma

Long-acting beta2-agonists versus anti-leukotrienes as add-on therapy to inhaled corticosteroids for chronic asthma

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