Long-term, placebo-controlled trial of ketotifen in the management of preschool children with asthma.

Forty-seven children with chronic asthma, aged 2 to 6 years, completed a double-blind, placebo-controlled, crossover trial of ketotifen, 1 mg twice daily, in the prophylaxis of asthma. The study period covered two 24-week periods preceded by a 4-week run-in and separated by a 4-week washout. When symptoms, concomitant medication, frequency of acute exacerbations, and parental and physician preferences were analyzed, there were no significant differences between active and placebo treatments. The results suggest that ketotifen has no place in the management of young children with frequent asthma.

RCT Entities:   Population Interventions Outcomes