Original ArticleComparative Efficacy and Safety of Low-dose Fluticasone Propionate and Montelukast in Children with Persistent Asthma
Section snippets
Patients
Children 6 to 12 years of age were enrolled in the study if they had at least a 6-month history of chronic asthma, as defined by the American Thoracic Society,25 and required the use of short-acting β2-agonist bronchodilators over the 3 months immediately before the study. Patients were required to have a baseline FEV1 (forced expiratory volume in 1 second) of 60% to 85% of predicted values,26 with an adjustment for African-Americans.27 To confirm the diagnosis of asthma, patients had to
Disposition and Demographics
Patients were recruited for the study from September 2000 until July 2002. Baseline demographics, asthma history, and pulmonary function of 342 pediatric patients who met entry criteria and were randomized to treatment with either 50 μg FP twice daily (n = 172) or MON 5 mg once daily (n = 170), were not significantly different (Table I). During the treatment period, five patients (3%) in the FP group received rescue oral corticosteroids compared with seven (4%) in the MON group. The mean study drug
Discussion
The choice of an appropriate, long-term therapeutic agent is a key step in controlling symptoms, improving pulmonary function, and attempting to alter the natural progression of childhood asthma. Recommendations in the NHLBI and American Academy of Pediatrics guidelines for the use of inhaled corticosteroids as the preferred treatment for managing persistent asthma in children are supported by extensive evidence-based research. Alternative treatments include cromolyn, leukotriene modifiers,
References (46)
- et al.
A comparative study of the effects of an inhaled corticosteroid, budesonide, and a β2-agonist, terbutaline, on airway inflammation in newly diagnosed asthma: a randomized, double-blind, parallel-group controlled trial
J Allergy Clin Immunol
(1992) - et al.
Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in a large pediatric population with persistent asthma
J Allergy Clin Immunol
(1998) - et al.
Efficacy and safety of dry powder fluticasone propionate in children with persistent asthma
Ann Allergy Asthma Immunol
(2000) - et al.
Fluticasone propionate 50 μg b.i.d. versus 100 μg b.i.d. in the treatment of children with persistent asthma
Clin Ther
(1998) - et al.
A randomized, double-blind trial of the effect of treatment with montelukast on bronchial hyperresponsiveness and serum eosinophilic cationic protein (ECP), soluble interleukin 2 receptor (sIL-2R), IL-4, and soluble intercellular adhesion molecule 1 (sICAM-1) in children with asthma
J Allergy Clin Immunol
(2002) - et al.
Low dose inhaled fluticasone propionate versus oral zafirlukast in the treatment of persistent asthma
J Allergy Clin Immunol
(2000) - et al.
Low-dose fluticasone propionate compared with montelukast for first-line treatment of persistent asthma: a randomized clinical trial
J Allergy Clin Immunol
(2001) - et al.
The impact of a large-scale population-based asthma management program on pediatric asthma patients and their caregivers
Ann Allergy Asthma Immunol
(2003) - et al.
The economic burden of asthma in US children: estimates from the National Medical Survey
J Allergy Clin Immunol
(1999) - et al.
Efficacy and safety of low-dose fluticasone propionate compared with montelukast for maintenance treatment of persistent asthma
Mayo Clin Proc
(2002)
Nocturnal awakening caused by asthma in children with mild-to-moderate asthma in the Childhood Asthma Management Program
J Allergy Clin Immunol
Comparison of asthma costs in patients starting fluticasone propionate compared to patients starting montelukast
Respir Med
Growth in asthmatic children treated with fluticasone propionate
J Pediatr
National Asthma Education and Prevention Program Report: guidelines for the diagnosis and management of asthma—update on selected topics, 2002. National Heart, Lung, and Blood Institute, National Institutes of Health
J Allergy Clin Immunol
Practical guideline for the diagnosis and management of asthma
Effect of short-term treatment with low-dose inhaled fluticasone propionate on airway inflammation and remodeling in mild asthma: a placebo-controlled study
Am J Respir Crit Care Med
Inhaled steroids and the risk of hospitalization for asthma
JAMA
Low-dose inhaled corticosteroid therapy and risk of emergency department visits for asthma
Arch Intern Med
Impact of inhaled anti-inflammatory therapy on hospitalization and emergency department visits for children with asthma
Pediatrics
Low-dose inhaled corticosteroids and the prevention of death from asthma
N Engl J Med
Manufacturer's prescribing information
The effect of inhaled fluticasone propionate in the treatment of young asthmatic children: a dose comparison study
Am J Respir Crit Care Med
Montelukast for chronic asthma in 6- to 14-year old children: a randomized, double-blind trial
JAMA
Cited by (82)
Overweight/obesity status in preschool children associates with worse asthma but robust improvement on inhaled corticosteroids
2018, Journal of Allergy and Clinical ImmunologyThe use of inhaled corticosteroids in pediatric asthma: Update
2016, World Allergy Organization JournalCitation Excerpt :In a meta-analysis that compared initiation of LABA/ICS, versus ICS of the same dose in steroid-naïve adults and children aged 6 years and above for asthma control, the LABA/ICS group had slight reduction in symptoms and rescue β2-agonist use but there was no difference to exacerbations requiring oral corticosteroids or rate of hospital admissions [65]. Various clinical trials [66–71] have demonstrated that ICS is superior to LTRA as monotherapy for asthma control; most of these studies were in children aged 6 years and older, with the exception of Szefler et al. [67] who demonstrated the superiority of ICS over LTRA in children aged 2–8 years. In contrast, in a large retrospective cohort study in children aged 4–17 years, LTRA appeared to be as effective as ICS upon initiation for asthma control.
Asthma in Older Children: Special Considerations
2016, Pediatric Allergy: Principles and Practice: Third EditionDemographic predictors of leukotriene antagonist monotherapy among children with persistent asthma
2014, Journal of PediatricsUse of Leukotriene Receptor Antagonists Are Associated with a Similar Risk of Asthma Exacerbations as Inhaled Corticosteroids
2014, Journal of Allergy and Clinical Immunology: In PracticeAntileukotriene Therapy in Asthma
2014, Middleton's Allergy: Principles and Practice: Eighth Edition
Supported by a grant from GlaxoSmithKline Inc., Research Triangle Park, North Carolina.
Disclaimer: Dr Ostrom has received consultant/grant/research support from the following companies: Abbott, AstraZeneca, Aventis, Merck, Bristol-Myers Squibb, Eli Lilly, Fisons, Forest, GlaxoSmithKline, Hoffmann-LaRoche, McNeil Consumer Products, Mead Johnson, Muro, Novartis, Parke-Davis, Pfizer, Rhone-Poulenc Rorer, Sandoz, Schering-Plough, Sepracor, Synergen, 3M Pharmaceuticals, and Wallace and Warner Lambert. William R. Lincourt, Dr Lisa D. Edwards, Kathleen M. Hanson, Dr Jacqueline R. Carranza Rosenzweig, and Dr Courtney Crim are employees of GlaxoSmithKline, Inc.