Budesonide inhalation suspension versus montelukast in children aged 2-4 years with mild persistent asthma

Published Online: November 29, 2012

The management of persistent asthma in young children can be challenging as they may lack the required coordination to use some inhaler devices. In these patients, nebulizers offer an alternative delivery route. Current guidelines recommend inhaled corticosteroids (ICS) as the preferred treatment of childhood persistent asthma1,2 with leukotriene receptor antagonist (LTRA) therapy proposed as an alternative. A previous study by Szefler et al3 in The Journal of Allergy and Clinical Immunology has shown that the ICS budesonide as an inhalation suspension (BIS) and the LTRA montelukast provided acceptable asthma control while overall measures favored BIS in children with mild persistent asthma aged 2–8 years over a 1 year period.

In a recent article published in The Journal of Allergy and Clinical Immunology: In Practice, Szefler et al performed a sub-analysis on their original study3 to determine whether the differences in asthma outcomes observed between BIS and montelukast were still present in the very young children with mild asthma, namely those aged 2–4 years, over the same 1 year period. Children received either BIS 0.5 mg or montelukast 4 mg once daily for 52 weeks. Children could also receive a short-acting bronchodilator as-needed should their asthma worsen. Increased use of the short-acting bronchodilator was indicative of asthma worsening and children’s therapy was temporarily increased to twice-daily BIS or oral corticosteroids for mild or severe asthma worsening, respectively.

Two hundred and two children received either BIS or montelukast. While there was no difference between the BIS and montelukast groups in the median time to first additional asthma medication being needed (183 vs 86 days; the longer the time the better the asthma control), there were significantly fewer children in the BIS group vs montelukast group that required oral steroids at 52 weeks (p=0.022), the rate of additional oral steroid therapy was lower (p=0.008), as was the rate of additional courses of medication (p=0.003); all of these findings together suggest improved asthma control with BIS. Interestingly, this greater improvement in asthma control seen with BIS was apparent to the caregivers as they reported a significantly greater improvement in their ability to manage the child’s asthma symptoms. Both drugs were well tolerated and no new safety findings or concerns emerged in these young children.

The authors’ conclude that the results of this analysis reinforce those of the initial study and suggest that both BIS and montelukast are effective and well tolerated asthma medications in children 2–4 years of age with mild asthma, with potentially greater benefits for BIS than for montelukast.

1. Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention [updated 2011].

2. National Institutes of Health National Heart Blood and Lung Institute. Guidelines for the Diagnosis and Management of Asthma (Epr-3). Full report 2007.

3. Szefler SJ, Baker JW, Uryniak T, Goldman M, Silkoff PE. Comparative study of budesonide inhalation suspension and montelukast in young children with mild persistent asthma. J Allergy Clin Immunol 2007;120:1043-50.

The Journal of Allergy and Clinical Immunology: In Practice is an official journal of the AAAAI, focusing on practical information for the practicing clinician.

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