Montelukast for Chronic Asthma in 6- to 14-Year-Old Children

Abstract

; for the Pediatric Montelukast Study Group Context.-Leukotrienes are important mediators of asthma by causing bronchoconstriction, mucous secretion, and increased vascular permeability. Studies using compounds that block leukotrienes have demonstrated improvement in asthma control in adults and adolescents, but children younger than 12 years, for whom asthma is the most common chronic disease, have not been studied. Objective.-To determine the clinical effect of montelukast, a leukotriene receptor antagonist, in 6-to 14-year-old children with asthma. Design.-Eight-week, multicenter, randomized, double-blind study. Setting.-Forty-seven outpatient centers at private practices and academic medical centers in the United States and Canada. Patients.-A total of 336 children with forced expiratory volume in 1 second (FEV 1) between 50% to 85% of the predicted value, at least 15% reversibility after inhaled ␤-agonist administration, a minimal predefined level of daytime asthma symptoms, and daily ␤-agonist use. Concomitant inhaled corticosteroids at a constant daily dose were used by 39% of patients receiving montelukast and 33% receiving placebo. Intervention.-After a 2-week placebo run-in period, patients received either montelukast (5-mg chewable tablet) or matching-image placebo once daily at bedtime for 8 weeks. Main Outcome Measure.-Morning FEV 1 percent change from baseline. Results.-Mean morning FEV 1 increased from 1.85 L to 2.01 L in the montelukast group and from 1.85 L to 1.93 L in the placebo group. This represents an 8.23% (95% confidence interval [CI], 6.33% to 10.13%) increase from baseline in the montelukast group and a 3.58% (95% CI, 1.29% to 5.87%) increase from baseline in the placebo group (PϽ.001 for montelukast vs placebo). Conclusion.-Montelukast improves morning FEV 1 in 6-to 14-year-old children with chronic asthma.

The effect of montelukast on respiratory symptoms and lung function in wheezy infants

“…In placebo-controlled studies, montelukast has been reported to be safe and effective in school-aged children with persistent symptoms [3], as well as in pre-school children with persistent [4] or intermittent symptoms [5]. LTRAs block the action of cysteinyl leukotrienes, which catalyse the inflammatory cascade emerging from eosinophils, mast cells and alveolar macrophages [19].…”

“…Leukotriene-receptor antagonists (LTRA) have been proposed as an alternative therapy for all age groups [1,2]. The LTRA montelukast has been claimed to achieve improvements in asthma control outcomes [3][4][5], lung function, airway responsiveness [3,6,7] and exhaled nitric oxide fraction (FeNO) [8] when used as monotherapy in children as young as 2 yrs of age. Although many trials have demonstrated that montelukast is beneficial and well tolerated in older children, few trials have been conducted in infants and very young children with wheeze.…”

High-performance liquid chromatographic determination of montelukast sodium in human plasma: Application to bioequivalence study

“…1a), is a potent and specific cys-teinyl leukotriene D 4 (LTD 4 ) receptor antagonist [1,2], which is being used in the treatment of asthma [3][4][5][6][7][8]. The oral absorption of montelukast is rapid and complete with an average bioavailability of 63% to 73%.…”

“…This injection protocol was repeated after 1,3,8,11,15,22,25, and 30 days of storage of this solution between 4 and 8°C.…”

Effects of Leukotriene Receptor Antagonists on Peripheral Eosinophil Counts and Serum IgE Levels in Children with Food Allergy

“…[12] The clinical effect of montelukast for pediatric asthma was first reported in 1998. [13] It has been used since that time, and its effectiveness is recognized worldwide. [14] Meanwhile, the effectiveness of pranlukast, a novel LTRA developed in Japan, for the treatment of asthma is also confirmed in the Western world.…”