Efficacy of Zaditen (ketotifen) in wheezy infants and young children.

This was a double-blind, randomised evaluation of the efficacy and safety of Zaditen in comparison with placebo in infants and young children (aged 6-36 months). These children either had (i) at least 2 episodes of wheezing over 8 weeks, or (ii) persistent wheeze over 4 weeks, prior to entering into the study. In the doctor's opinion, the group treated with Zaditen had more improvement in symptomatology (p < 0.05). They were more likely to have reduced or discontinued bronchodilators. They showed trends of improvement of symptom scores in night cough, wheeze and sputum production. These differences, however, did not reach statistical significance. There were no major adverse reaction of note.