Phipatanakul W, Greene C, Downes SJ, et al. Ann Allergy Asthma Immunol. 2003;91:49–54
Purpose of the Study.
To evaluate whether montelukast as adjunctive therapy improves asthma control and whether montelukast has corticosteroid-sparing effects among children treated with low or moderate inhaled corticosteroid (ICS) doses.
Thirty-six children, 6 to 14 years of age, with mild/moderate persistent asthma who were being maintained with a stable low or moderate dose of ICS were randomly assigned to receive montelukast or matching placebo.
After a single-blind, run-in period of 2 weeks for assessment of incomplete control of asthma symptoms (period I), qualified subjects were randomized in a double-blind, placebo-controlled, 2-period, parallel-group study designed to investigate the effects of montelukast as 4-week adjunctive therapy (period II) and to investigate its effects on the ability to taper the dose of ICS during a 20-week period (period III). Subjects maintained daily asthma diaries, and spirometry was performed monthly.
In period II, both the mean number of β2-agonist rescue-free days per week and the difference in the number of rescue-free days were significantly greater for the montelukast-treated subjects, compared with the placebo-treated subjects (6 days vs 3.18 days, P = .0002; 4.47 days vs 0.05 days, P = .0001; respectively). In period III, the percentage changes in ICS doses were not statistically significantly different between the montelukast and control groups (P = .10), but subjects receiving montelukast experienced an average 17% reduction in ICS dose, compared with a 64% increase in ICS dose among subjects receiving placebo. Also, although the findings were not statistically different, 32% of subjects receiving montelukast were weaned completely off the ICS, compared with 18% in the placebo group.
Montelukast significantly increased the number of rescue-free days among symptomatic children with mild/moderate persistent asthma.
Although this was a pilot study with a small patient population, the results are encouraging for those who care for children with asthma, as well as for parents, who are often concerned about the use of corticosteroid medications. Additional studies with a larger population of patients with mild/moderate asthma and a group of patients with severe asthma are warranted.