Montelukast as an episodic modifier for acute viral bronchiolitis: a randomized trial.

This study was designed to evaluate the effect of once-daily montelukast therapy on the clinical progress and the cytokine profile of patients with acute viral bronchiolitis. A randomized, double-blind, placebo-controlled trial included 85 patients (mean age, 3.5 +/- 2.35 months), clinically diagnosed as first-episode acute bronchiolitis in addition to 10 healthy controls of matched age and sex. Patients were randomly assigned to receive either montelukast (4-mg sachets; n = 47) or placebo (n = 38) daily from the time of admission until discharge. The primary outcome measure was the length of hospital stay (LOS), and clinical severity scores (CSs) and changes in plasma levels of interferon gamma and interleukin-4 were secondary outcomes. LOS for the montelukast group was found to be significantly lower than that of the placebo group (p < 0.05). This effect was also found at nonsignificant levels among patients with a positive family history of asthma or allergy. Moreover, cases receiving montelukast showed lower CSs all through the hospital stay that were significant in the first 24 hours (p < 0.05). Montelukast is probably of benefit as an episodic modifier in infants with acute viral bronchiolitis.