Kids With Asthma Lose Fewer School Days on Leukotriene Antagonist

MELBOURNE, Australia, Feb. 15 -- For children with intermittent asthma, a short course of Singulair (montelukast) given at the first sign of an episode may reduce acute care visits, found Australian investigators.

Children with intermittent asthma who were given the leukotriene synthesis inhibitor had fewer unscheduled doctor's visits and lost less school time than children given placebo, said pulmonologist Colin F. Robertson, M.D., of Royal Children's Hospital here, and colleagues. The drug-maker, Merck, funded the study.

The use of Singulair did not, however, have a significant effect on either specialty visits, hospitalizations, duration of asthma episodes, or the use of beta-agonists or prednisolone, the authors reported in the second February issue of the American Journal of Respiratory and Critical Care Medicine.

"A key component of the study was the impact of asthma on the family, as measured by days absent from school or childcare, nights of disturbed sleep, and the number of parent days lost from work," said Dr. Robertson. "Furthermore, the strategy of parent-initiated therapy required children on average to take the study drug only 30 days per year, rather than 365, providing a further cost-benefit for the family."

To see whether a short course of Singulair might be able to modify the severity of an asthma episode, the authors enrolled 220 children with doctor-diagnosed intermittent asthma into a one-year study. The children, ranging in age from two to 14 years, were randomly assigned in a double-blinded fashion to either Singulair or placebo. Singulair was delivered in a dose of 4 mg at bedtime to children ages two to five, and 5 mg for children age six to 14.

Treatment with either Singulair (107 children) or placebo (113) was started by parents at the onset of each upper respiratory tract infection or asthma symptoms, and was continued for a minimum of seven days, or until symptoms had resolved for 48 hours.

There were at total of 681 treated episodes over the one year of the study, 345 in patients assigned to Singulair and 336 for those assigned to placebo, among 202 patients.

The authors found that patients assigned to Singulair had 163 "unscheduled health-care resource utilizations" for asthma compared with 228 in the placebo group. The odds ratio for an unscheduled visit among patients on Singulair was 0.65 (95% confidence interval, 0.47-0.89).

Symptoms, recorded on diary cards, were 14% lower among patients on Singulair, and night awakenings due to asthma symptoms were 8.6% lower (P=0.043).

Children on Singulair had 37% fewer absentee days, and their parents lost 33% fewer work days (P<0.0001 for each comparison).

Dr. Robertson has been a member of drug advisory boards and has received lecture fees and educational grants from Merck, the maker of Singulair and funder of the study, and he has received a consultancy fee from the company. Two of his co-authors are employees of the company, and others are also advisory board members or have received speaking fees from Merck, or both.