Double-blind study on the influence of picumast dihydrochloride on safety-related performance

The antiallergic drug picumast dihydrochloride (3,4-dimethyl-7-[4-(4-chlorobenzyl)piperazin-1-yl]propoxycoumar ine dihydrochloride) was tested in two doses, 2 mg/d and 4 mg/d, in a double-blind group comparison versus placebo using a sample of 48 healthy adult volunteers to determine any effects on safety-related performance in the initial phase of treatment and at steady state. Besides seven test procedures covering concentration and reaction performance, visual orientation, eye-hand coordination and vigilance, a survey of subjective well-being was taken using two different methods. Additionally, after reaching steady state, the tests took place and the survey of well-being was carried out in combination with 0.5% blood alcohol concentration. With both doses of picumast dihydrochloride neither statistically significant nor clinically relevant effects were established in the performance or the well-being of the subjects. This also applies in the case of combination with ethyl alcohol.