Our aim was to investigate the effectiveness of
montelukast in recurrently wheezy infants. We randomised 113, 6-24-month-old children with recurrent
wheezing to receive either placebo or
montelukast daily for an 8-week period. The primary end-point was symptom-free days. The secondary aims were to evaluate the effect of
montelukast on rescue medication, on lung function, airway responsiveness and exhaled
nitric oxide fraction (FeNO). Clinical response and FeNO were determined, the functional residual capacity (FRC) and specific airway conductance (sGaw) were measured using an infant whole-body plethysmograph, the maximal flow at functional residual capacity (V'max,FRC) was recorded using the squeeze technique and airway responsiveness was evaluated by performing a dosimetric
methacholine challenge test. There was no significant difference in changes in weekly symptom-free days between the
montelukast and the placebo group (3.1-3.7 days versus 2.7-3.1 days, p = 0.965). No significant differences were detected in the secondary end-points, i.e. use of rescue medication, FRC, sGaw, V'max,FRC, FeNO or airway responsiveness between groups.
Montelukast therapy did not influence the number of symptom-free days, use of rescue medication, lung function, airway responsiveness or airway
inflammation in recurrently wheezy, very young children.