RESUMO
BACKGROUND: Various trials showed benefit of the prophylactic agent ketotifen in prevention of recurrent wheezing in young children, but no such clinical trial with loratadine or comparison trial is available. OBJECTIVE: To study the efficacy and safety of loratadine syrup compared with ketotifen and placebo in prevention of recurrent wheezing in young children. MATERIAL AND METHOD: Randomized double-blind placebo controlled trial on 90 recurrent wheezing children aged less than 6 years old was done. Children were randomized to receive loratadine, ketotifen syrup, or placebo with dose of 0.25 cc/kg once a day for four months. Blood biochemistry (CBC, LFT) and EKG were performed pre and post treatment period. Assessment of symptoms--wheezing and night cough including use of bronchodilators was done daily via patient diary card. Subjects were asked to do monthly visits to the clinic for physical examination. At those visits, the doctors questioned the patients about adverse event. RESULT: Of the 90 children enrolled, 12 dropped out. Thus, 27 children remained in the loratadine, 26 in the placebo, and 25 in the ketotifen group. The demographic data were comparable among the three treatment groups. It was noted that wheezing decreased significantly at 2 months in the ketotifen (p = 0.008) and at 3 months in the loratadine (p = 0.029) but not in the placebo group. Coughing at night decreased significantly at 3 months in both the loratadine (p = 0.005) and the ketotifen (p = 0.036) group. The use of bronchodilator drug was significantly decreased at 2 months in the ketotifen (p = 0.028) and placebo (p = 0.025) group, and at 3 months in the loratadine (p = 0.009) group. Only a few patients had mild adverse events in all groups. CONCLUSION: Loratadine and ketotifen are safe and effective significantly in prevention of recurrent wheezing in young children.