Asthma and lower airway diseaseAzithromycin or montelukast as inhaled corticosteroid–sparing agents in moderate-to-severe childhood asthma study
Section snippets
Study participants
Participants were recruited at 5 CARE Network centers from August 2006 to March 2007 (for more details, see Appendix E1 in this article's Online Repository at www.jacionline.org). Each center's institutional review board approved the study, and parents/guardians provided informed consent, with verbal assent given by children younger than 7 years and written assent given by older children.
Inclusion criteria were physician-diagnosed asthma, age of 6 to less than 18 years, and demonstration of
Study progress
Flow of participants into study enrollment was slower than expected, with a rate of 22 per month compared with the expected 56 per month. The 292 enrolled participants had historical characteristics consistent with moderate-to-severe persistent asthma, with 82% taking medium- to high-dose ICSs (800 μg of budesonide equivalent or higher): almost one half of these patients' symptoms were inadequately controlled before study entry by symptom report. Eighteen percent of enrolled participants had
Discussion
Moderate-to-severe persistent asthma in children accounts for a significant proportion of both morbidity and mortality from asthma, but interventions to improve these outcomes have not been thoroughly or systematically studied. The MARS trial was an attempt to study this group of children using therapeutic interventions considered to be relevant to their disease course given that significant side effects can occur from the high doses of ICSs required to control symptoms and prevent morbidity.
References (22)
- et al.
Severe asthma: an overview
J Allergy Clin Immunol
(2006) - et al.
Efficacy and safety of troleandomycin therapy in severe, steroid-requiring asthmatic children
J Allergy Clin Immunol
(1993) - et al.
Erthromycin inhibits neutrophil chemotaxis in bronchoalveoli of diffuse panbronchilits
Chest
(1994) - et al.
Montelukast added to budesonide in children with persistent asthma: a randomized, double-blind, crossover study
J Pediatr
(2001) - et al.
Inhibition of methylprednisolone elimination in the presence of clarithromycin therapy
J Allergy Clin Immunol
(1999) - et al.
Achieving and maintaining asthma control in an urban pediatric disease management program: the Breathmobile Program
J Allergy Clin Immunol
(2007) - et al.
Predicting episodes of poor asthma control in treated patients with asthma
J Allergy Clin Immunol
(2006) - et al.
Effect of low-dose troleandomycin on glucocorticoid kinetics and airway hyperresponsiveness in severely asthmatic children
Ann Allergy
(1990) National Asthma Education and Prevention Program Expert Panel Report. Guidelines for the diagnosis and management of asthma—update on selected topics 2002
(2002)National Asthma Education and Prevention Program expert panel report. Expert panel report 3: guidelines for the diagnosis and management of asthma
(2007)
Side-effects of fluticasone in asthmatic children: no effects after dose reduction
Eur Respir J
Cited by (117)
A systematic review and meta-analysis of macrolides in the management of adult patients with asthma
2024, Allergology InternationalDifficult-to-Treat Asthma Management in School-Age Children
2022, Journal of Allergy and Clinical Immunology: In PracticeDiagnosing, Monitoring and Treating Asthma
2021, Encyclopedia of Respiratory Medicine, Second EditionAdvances in understanding and reducing the burden of severe asthma in children
2020, The Lancet Respiratory Medicine
Disclosure of potential conflict of interest: L. B. Bacharier has received honoraria from AstraZeneca, Genentech, GlaxoSmithKline, Merck, and Aerocrine and has served on an advisory board for Schering-Plough. S. J. Szefler has served as a consultant for AstraZeneca, GlaxoSmithKline, Aventis, Genentech, and Merck and has received research support from the National Institutes of Health (NIH), the National Heart, Lung, and Blood Institute (NHLBI), and Ross Pharmaceuticals. R. S. Zeiger has served as a consultant for Aerocrine, AstraZeneca, GlaxoSmithKline, Genentech, Merck, Schering, and Novartis and has received research support from Sanofi Aventis and Genentech. V. M. Chinchilli has received research support from the NIH and NHLBI. F. D. Martinez has received lecture fees from and has served on an advisory board for Merck and has served as a consultant for GlaxoSmithKline. R. F. Lemanske has received speaker honoraria from Merck; has served as a consultant for MAP Pharmaceuticals; and has received research support from the NHLBI. D. T. Mauger has received research support from the NIH. W. J. Morgan has served as a consultant for the Cystic Fibrosis Foundation and Genentech and has received research support from the NIH. C. A. Sorkness has served as a consultant for GlaxoSmithKline and Novartis and has received research support from Novartis, the NHLBI, and the National Institute of Allergy and Infectious Diseases (NIAID). I. M. Paul has served as a consultant for McNeil Consumer Healthcare, the Consumer Healthcare Products Association, and Reckitt Brackiser Healthcare International and has received research support from GlaxoSmithKline, the National Honey Board, and Johnson & Johnson. T. Guilbert has received honoraria for serving as a consultant, speaker, or both for GlaxoSmithKline, AstraZeneca, Merck, and Antidote (formerly World Medical Conferences CME Programs) and has received research support from Altus Pharmaceuticals, Inspire Pharmaceuticals, and the NIH. M. Krawiec has served on the speakers' bureau for Merck and GlaxoSmithKline; has served as a consultant on a peer-reviewed publication for Adelphi; has served as a consultant for Parexel and Novartis; and has provided legal consultation or expert witness testimony on the topic of pediatric asthma. R. Covar has served as a consultant for Merck and has received research funding from Ross Abbott Laboratories and AstraZeneca. G. Larsen has served on an asthma advisory board for Genentech and has received research funding from the NIH. The rest of the authors have declared that they have no conflict of interest.
- ∗
See Appendix E1 in this article's Online Repository at www.jacionline.org for a list of the Childhood Asthma Research and Education Network members.