Onset and duration of attenuation of exercise-induced bronchoconstriction in children by single-dose of montelukast

Single-dose montelukast attenuates exercise-induced bronchoconstriction (EIB) in adults within 2 hours postdose and lasting through 24 hours. This study evaluated the onset and duration of EIB attenuation in children after a single dose of montelukast. A randomized, double-blind, placebo-controlled, two-period crossover study was performed. Patients (n = 66) aged 4‐14 years, with preexercise forced expiratory volume in 1 second of (FEV₁) ≥70% predicted and maximum percentage fall in FEV₁ of ≥20% at two screening exercise challenges were eligible. Patients were to receive single-dose montelukast (4 or 5 mg) or placebo before performing standardized exercise challenges at 2 and 24 hours postdose. A 3- to-7-day washout separated the two crossover periods. The primary end point was maximum percentage fall in FEV₁ after exercise challenge 2 hours postdose. Secondary end points included maximum percentage fall in FEV₁ after the 24-hour postdose challenge; each of the following at 2 and 24 hours postdose—maximum percentage fall in FEV₁ categorized as <10%, 10‐20%, or >20%; area under the curve (AUC) during 60 minutes postchallenge; time to recovery of FEV₁ to within 5% of preexercise baseline; and need for rescue medication. The mean maximum percentage fall in FEV₁ after the 2-hour postdose exercise challenge was significantly attenuated after single-dose montelukast compared with placebo (15.35% versus 20.00%; p = 0.020). Montelukast was also significantly more effective than placebo for maximum percentage fall after the 24-hour challenge (12.92% versus 17.25%; p = 0.005), the categorized maximum percent fall in FEV₁ at 2 hours (p = 0.034), and AUC at 2 hours (p = 0.022) and 24 hours (p = 0.013). Single-dose montelukast provided rapid and sustained EIB attenuation in children. Clinicaltrials.gov identifier: NCT00534976