Double-blind Placebo-controlled Study of Oxatomide in the Treatment of Childhood Asthma

Oxatomide is an orally active H1-histamine receptor antagonist. It has been demonstrated to have therapeutic efficacy in the treatment of allergic diseases in adults. The aim of this study was to evaluate the efficacy and safety of oxatomide in the treatment of asthma in children. Sixty-four asthmatic children of both sexes, aged between 5 and 16 years, were enrolled in this double-blind, placebo-controlled trial with a duration of 4 months. Patients were randomized chosen to receive either oxatomide with a daily dose of 1 to 2mg/kg body weight or a placebo twice daily. Clinical evaluations including pulmonary function tests and immunological studies. The patients’ impression on the effect of treatment also were recorded during the study. The effects of bronchodilatation and normalizing pulmonary function were observed 2 months after oxatomide treatment. The levels of eosinophil cationic protein and total asthma symptom scores were significantly reduced during treatment with oxatomide. There was no significant change in total IgE or IgG4 before or after treatment in either the treatment or control groups. During the study, two (5.8%) oxatomide treated patients reported slight drowsiness and one (29%) reported body weight gain. Routine laboratory tests showed no significant alterations. In conclusion, oxatomide was generally well tolerated in this study and may have the potential of being an effective treatment for childhood asthma.