Growing morbidity and mortality rates call for research towards more effective methods of preventing asthma. During the last decade several groups have reported the results of natural history and asthma prevention studies. However, the attempt to prevent development of asthma in genetically predisposed children, has not resulted in a generally accepted management scheme. The aim of this study was to evaluate the effectiveness of ketotifen in preventing the onset of asthma in infants considered to be at high risk of developing the disease, but who had no history of respiratory obstruction. These children have been described as preasthmatic. In this double-blind, placebo-controlled, parallel study, 100 infants with a family history of major allergy and elevated serum IgE levels, but with no history of bronchial obstruction, were treated with either ketotifen (n = 50) or placebo (n = 50) over a 3-year period. There were no statistically significant differences between the two groups with regard to age, sex, degree of hereditary allergy, levels of serum IgE upon joining the study, and family smoking habits. At the end of 3 years, only four of the 45 infants who had received ketotifen had developed asthma (9%). Of the 40 children given placebo, 14 had developed asthma (35%) (P = 0.003). These results suggest that ketotifen is effective in preventing the onset of asthma in preasthmatic children.