Leukotriene receptor antagonists: efficacy and safety in children with asthma.

To date, only one study of chronic use of a leukotriene receptor antagonist in children has been published. The efficacy and safety of montelukast in children 6-14 years of age with asthma (n = 336) was studied during an 8-week, double-blind, placebo-controlled trial. There was significantly greater improvement in forced expired volume in 1 sec (FEV(1)) from baseline for the montelukast group (8. 23%) compared to the placebo group (3.58%). There was a significant decrease in use of beta agonists for symptom relief and a significant decrease in the percentage of days and percentage of patients with asthma exacerbations. An asthma-specific quality of life questionnaire revealed significant overall improvement in quality of life and significant improvement in the quality of life domains for symptoms, activity, and emotions. Adverse effects were not significantly different for montelukast than for placebo, with the exception of allergic rhinitis which was more prevalent in the placebo group. A 6-month open follow-up of patients from the above study was undertaken. Effects of montelukast on FEV(1) were consistent over the 6 months, with the increase in FEV(1) not significantly different from a small control group treated with beclomethasone. Quality of life remained significantly improved throughout the open treatment period. In conclusion, leukotriene receptor antagonists are of value for the treatment of children with asthma. Copyright 2000 Wiley-Liss, Inc.

RCT Entities:   Population Interventions Outcomes