A multicenter study with ketotifen (Zaditen).

Seven hundred and thirty-three atopic asthmatic patients were entered into two multicenter double-blind double-placebo controlled studies comparing the prophylactic effects of ketotifen (445 patients), placebo (143 patients), disodium cromoglycate (72 patients) and theophylline (73 patients). The primary measure of therapeutic effects was a decrease in concomitant medication without a significant increase in symptomatology or a decrement in pulmonary function: in both studies ketotifen was shown to be an effective and safe therapeutic agent at an oral dose of 1 mg bid. The positive control, DSCG, was also shown to be effective when used properly, while theophylline did not show a significant prophylactic effect.