The effect of montelukast on respiratory symptoms and lung function in wheezy infants.

Our aim was to investigate the effectiveness of montelukast in recurrently wheezy infants.We randomized 113, 6 to 24 month old children with recurrent wheezing to placebo or montelukast daily for a 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 (AR) and exhaled nitric oxide (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'maxFRC) was recorded using the squeeze technique and AR was evaluated by performing a dosimetric methacholine challenge test.There was no significant difference in changes towards weekly symptom-free days between the montelukast and the placebo group (3.1 to 3.7 days vs 2.7 to 3.1 days, p=0.965). No significant differences were detected in the secondary end points, i.e. use of rescue medication, in FRC, sGaw, V'maxFRC or FeNO values or AR between groups.Montelukast therapy did not influence the number of symptom-free days, use of rescue medication, lung function, airway responsiveness or on airway inflammation in recurrently wheezy, very young, children.