A prospective, randomized, placebo-controlled, double-blind study of montelukast's effect on persistent middle ear effusion.

We conducted a prospective, randomized, placebo-controlled, double-blind study to determine if the leukotriene inhibitor montelukast is effective in eliminating persistent middle ear drainage in patients with otitis media with effusion (OME). Our study population was made up of patients aged 2 to 6 years who had had confirmed OME in one or both ears for at least 2 months. Patients were randomized to receive either placebo or 4 mg of montelukast daily for 1 month.

The effect of montelukast sodium on the duration of effusion of otitis media.

This study tests the hypothesis that montelukast sodium, a selective leukotriene receptor antagonist, will decrease the duration of the effusion of otitis media. Tympanometry and spectral gradient acoustic reflectometry were used to confirm the effusion of otitis media in patients between 2 and 12 years of age. Patients were treated with amoxicillin for 10 days and montelukast sodium or placebo for 30 days in a random, double-blind manner.