SAN FRANCISCO – Compared with placebo, a single dose of montelukast attenuated exercise-induced bronchoconstriction in children within 2 hours and lasted through 24 hours post dose, results from a small study found.
Although this treatment effect of montelukast has been observed in previously published studies of adults with exercise-induced bronchoconstriction, this is the first analysis of its kind in children with the condition.
“The ability to take a single tablet and have it last for 24 hours is probably more meaningful for children than for adults, because children often engage in unplanned physical activities more than adults do,” Dr. George Philip said in an interview during a poster session at the meeting.
In a multicenter study, Dr. Philip, senior director of clinical research at Merck Research Laboratories, North Wales, Pa., and his associates enrolled 66 children aged 6-14 years with preexercise forced expiratory volume in 1 second (FEV1) of 70% predicted or greater and a maximum fall in FEV1 of 20% or greater at two screening exercise challenges performed on a treadmill. Study participants were randomized to receive single-dose montelukast (4 or 5 mg) or placebo before the exercise challenges were performed at 2 and 24 hours post dose.
The primary end point was maximum percent fall in FEV1 after exercise challenge 2 hours post dose. Secondary end points included maximum percent fall in FEV1 after the 24-hour postdose challenge and each of the following end points at 2 and 24 hours post dose: maximum percent fall in FEV1 categorized as less than 10%, 10%-20%, and greater than 20%; area under the curve during the 60 minutes post challenge; and time to recovery to within 5% of preexercise baseline.
The mean age of patients was 11 years, and 56% were male. About three-quarters (74.2%) were white, 16.7% were black, and 9.1% were from other ethnic groups.
Dr. Philip reported that the mean percent fall in FEV1 was significantly better after the 2-hour postdose exercise challenge in the montelukast treatment group than in the placebo group (15.3% vs. 20%, respectively). Patients in the montelukast group also fared significantly better, compared with their counterparts in the placebo group, in maximum percent fall in FEV1 after the 24-hour postdose exercise challenge (12.92% vs. 17.25%, respectively); the categorized maximum percent fall at 2 hours (P = .034) though not at 24 hours (P = .061); and area under the curve at 2 hours (P = .022) and 24 hours (P = .013).
There were few clinical adverse events and no serious drug-related adverse events.