Montelukast in asthmatic patients 6 years–14 years old with an FEV₁ > 75%

SUMMARY

Objectives: Montelukast is a potent leukotriene receptor antagonist effective for treating asthma symptoms in adult and pediatric patients. The purpose of this analysis was to assess the clinical efficacy of montelukast, a potent leukotriene-receptor antagonist, in a subgroup analysis of patients aged 6 years–14 years with milder asthma, defined as a percentage predicted forced expiratory volume in 1 s (FEV₁) > 75% using data from a clinical trial of pediatric patients with a broad range of asthma severities.

Research design and methods: The original previously published clinical trial was an 8-week multi-center, randomized, double-blind, parallel-group study conducted in 47 centers in the United States and Canada. The study compared the efficacy of once daily montelukast 5 mg to placebo in patients 6 years–14 years old with persistent asthma and an FEV₁ ranging from 50% to 85% of predicted. A total of 87 patients in the montelukast group and 51 patients in the placebo group were selected from the original cohort of 336 patients based on percentage predicted FEV₁ of > 75%. The primary endpoint was percentage change in FEV₁ from baseline compared with placebo over 8 weeks of active treatment.

Results: Montelukast significantly improved the primary endpoint of percentage change in FEV₁ compared with placebo ( p = 0.005). Other efficacy endpoints were significantly improved on montelukast similar to efficacy in the original study.

Conclusion: Montelukast significantly improved FEV₁, clinic measured peak expiratory flow (PEF), reduced nocturnal awakenings, and improved quality of life in children with milder persistent asthma defined as an FEV₁ > 75% of predicted.

Key words: :

• Asthma, pediatric
• Efficacy
• FEV1
• Leukotriene receptor antagonist
• Quality of life