During the past decade, the inflammatory mechanisms that result in the clin
ical syndrome we call asthma have been emphasized in research, publications
, and the various asthma management guidelines. This information clearly em
phasizes the treatment of asthma with maintenance controller therapies earl
y after the onset of symptoms in all but the very mildest of patients. Unti
l the advent of the leukotriene receptor antagonists, nearly all of these m
aintenance therapies needed to be administered by inhalation through a vari
ety of devices and spacers. Inhalation of medication was necessary to eithe
r increase the amount of drug reaching the airways or to increase the thera
peutic index or drugs such as corticosteroids. Even under the best circumst
ances, this route of administration is difficult and expensive for many par
ents whose children have asthma. Now that oral controller therapies (leukot
riene receptor antagonists) are available for children, their role in clini
cal practice needs to be examined. The latest asthma management guidelines
classify asthma into four groups of severity, and base treatment recommenda
tions on the intensity of symptoms, need for rescue medications, and pulmon
ary function as measured by peak expiratory flow and forced expiratory volu
me in 1 sec (FEV1). The categories of mild intermittent, mild persistent, m
oderate persistent, and severe asthma in children will be addressed in this
presentation by reviewing the available data on the use of the leukotriene
receptor antagonist montelukast in children.
Mild intermittent asthma can be typified by exercise-induced asthma, a comm
on pediatric condition. In this often troublesome condition, montelukast de
monstrated effectiveness at the end of a once a day dose by blocking the ef
fects of this naturally occurring challenge. Drug regulatory approval of a
new drug also includes patients with more regular symptoms who are usually
classified as having persistent or moderate asthma. in these montelukast pe
diatric studies. approximately 40% of patients were already taking inhaled
corticosteroids. Patients had improvements in FEV1, symptoms, and rescue me
dication use, clearly showing an effect with once a day dosing. Pediatric d
ata in severe asthma patients are more limited, but in such patients a ther
apeutic trial of montelukast would seem preferable to using systemic cortic
osteroids or increasing inhaled steroids to a level where adverse effects h
ave an increasing potential of occurring.
Montelukast has been available in the United States since March 1998 and ha
s received excellent acceptance by physicians, parents, and patients. The 5
-mg chewable tablet administered once a day in the evening in children aged
6-14 years apparently fills a previously unmet need in the treatment of pe
diatric asthma. (C) 2000 Wiley-Liss. Inc.