The objective of this study was to evaluate the effect of fexofenadine on driver behavior, decision-making, and reaction time in a blinded, randomized, parallel, placebo-controlled study. A total of 259 male and female adult volunteers participated in a standardized BMW advanced driving test (the skid-pan test; Pretoria, South Africa) and a decision and reaction test of the Vienna Psychomotor Test System. The psychomotor test focused on mean decision times, mean reaction time, decision errors and reaction errors. After a baseline pretest run, the test was repeated 2.6 hours after ingesting either fexofenadine hydrochloride (180 mg) or placebo (the posttest; 1:1). Two hundred fifty-five volunteers were included in the final efficacy analysis (195 males and 60 females). There was a reduction in the road test time going from the pretest to the posttest, signifying a learning effect, and an increase in the decision time. Although there was a consistent increase in the number of errors committed in the road test, decision time, and reaction time, there were no significant differences between the placebo and the fexofenadine groups. Although significant differences were observed between men and women for the road test time (P < 0.001), decision time (P < 0.001), and reaction time (P = 0.003), there were no differences between the fexofenadine and placebo groups in these subgroups. No differences were found between the fexofenadine and placebo groups on reaction times, decision-making, driver behavior, or adverse effects. (Author/publisher)
Samenvatting