Treatment of wheezy infants and children with ketotifen.

An open study was carried out in 74 wheezy infants and children, average age 16 months, to assess the efficacy and tolerance of ketotifen given in the form of a syrup at a dosage of 0.02 to 0.03 mg/kg body weight twice daily over a period of 12 weeks. Treatment was assessed as being successful, by both parents and physician, in 62 (84%) of the patients. Wheeze completely disappeared in 42 (57%) patients, cough in 50 (67%) and bronchial hypersecretion in 47 (64%). Patients who developed a superimposed respiratory infection during the treatment period had milder symptoms than usual; these lasted for a shorter time and in most patients it was not necessary to give antibiotics. Forty-one of the 62 patients who had responded successfully to ketotifen suffered a relapse when treatment was withdrawn at the end of the trial period. Ketotifen was well-tolerated by the majority of patients. The side-effect most frequently reported by the parents was dry mouth, which occurred in 21 patients.