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Montelukast eases exacerbations in children with mild persistent asthma

Jairia Dela Cruz
21 Jun 2017

Control treatment with montelukast may effectively reduce acute exacerbations in preschool children with mild persistent asthma, according to a study from Japan.

A total of 93 children aged 1 to 5 years with mild persistent asthma (defined as symptoms occurring more than once a week but less than once a day by the Japanese guideline for childhood asthma [JGCA]) were randomized to receive montelukast 4 mg daily for 48 weeks (n=47; mean age 2.3 years; 47 percent male) or β2-agonists as needed (no-controller group; n=46; mean age 2.7 years; 35 percent male).

During the study period, acute exacerbations were reported in 13 patients in the montelukast group vs 23 patients in the no-controller group (28 vs 50 percent; mean number of exacerbations, 0.9 vs 1.9/year; p=0.027). [Allergol Int 2017;doi:10.1016/j.alit.2017.04.008]

The primary endpoint of number of acute asthma exacerbations prior to initiating step-up treatment with inhaled corticosteroids was significantly lower in the montelukast group (hazard ratio, 0.45; 95 percent CI, 0.21 to 0.92; p=0.033). Step-up treatment was given in 21 percent of patients in the montelukast group and in 41 percent in the no-controller group.

“Compared with as-needed β2-agonists, montelukast reduced the number of acute exacerbations by one in 1 year. This treatment effect is not large,” the authors noted.  “However, it has clinical meaning because acute exacerbations cause a considerable burden on children and their families including urgent care or emergency room visits. In addition, acute exacerbations sometimes increase the risk of life-threatening respiratory failure.”

They also pointed out that the proportion of patients who received step-up treatment and used β2-agonists was lower in the montelukast group, indicating that the drug prevented disease progression in younger children and that control treatment should be started in earlier disease stage.

In terms of safety, montelukast was well tolerated. The most common adverse events (AEs) reported were communicable diseases such as upper respiratory infection, hand-foot-and-mouth disease, acute sinusitis and croup. All AEs were mild or moderate in intensity, and none led to treatment discontinuation.

A cysteinyl leukotriene 1 receptor antagonist, montelukast has pleiotropic effect. Previous studies have reported that the drug ameliorates airway remodelling by blocking eosinophils-induced epithelial to mesenchymal transition, decreases airway smooth muscle mass and reduces the cytokine levels in bronchus. It has been also shown to suppress the initial immune response activated by dendritic cell functions and T-helper cell 2 cytokine production activated by type 2 innate lymphoid cells in the lung. [Biochem Biophys Res Commun 2014;449:351–356; Clin Exp Allergy 2011;41:116–128; J Allergy Clin Immunol 2013;132:205–213]

In managing preschool children, the JGCA recommends use of leukotriene antagonists in controller medications. In contrast to other guidelines, JGCA also cites that low-dose inhaled corticosteroids may be used in addition for those with symptoms more than once a month.

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