The protective effect of a new agent, ketotifen syrup, in the treatment of childhood asthma.

Twenty-two children with perennial extrinsic allergic asthma participated in a double-blinded, controlled, cross-over study of Ketotifen syrup during a 2 x 6-week period. The placebo was identical with the active drug in taste, colour, and consistency. The dosage level was, on weight basis, a little higher than the standard dosage for adults. The double-blinded investigation was supplemented with a 1 2-week open study of the tolerance for Ketotifen. This study also involved 22 patients, 12 new ones, and 10 from the double-blind study. The study showed Ketotifen to have no effect on changes in lung function (peak flow), on reduction in frequency of asthmatic attacks, or on consumption of additional medicine. The tolerance for Ketotifen was good, but physicians are advised to watch for increases in weight and decreases in blood pressure during tests on children which involve higher dosage levels.

RCT Entities:   Population Interventions Outcomes