[Clinical efficacy of Ebastine under placebo-controlled outdoors clinical study on cedar pollinosis]

Placebo-controlled outdoors clinical study was performed at the Utsunomiya City Forest Park surrounded by many cryptomerias on March 5, 2000, at the season of most cedar pollens, to evaluate the efficacy and its timing and duration of Ebastine. It was a fine weather on the day of the study, and so much cedar pollens as 235 pollens/cm2 were spreading at the park when it was measured at the park. In particular, the amount of cedar pollen for 2 hours from 10:00 a.m. when Ebastine was administered exceeded 50 pollens/cm2 per hour. The nasal symptoms of the placebo-treated subjects promptly aggravated during the time, while the symptoms of the subjects who received oral Ebastine showed the tendency to improve from 2 hours after oral administration under exposure of a large amount of cedar pollens, and the efficacy maintained until 10:00 a.m. at the next morning that passed 24 hours after administration. The results suggest that Ebastine promptly inhibited the symptom induced by the exposure of a large amount of pollens at the season of most cedar pollens and that once daily oral administration of Ebastine maintained the efficacy at least for 24 hours. It was also suggested that outdoors comparative clinical study at the season of cedar pollen was effective to observe and evaluate the natural clinical course of a patient's symptom and was useful for evaluation of clinical efficacy of anti-pollinosis drugs of various types, including an anti-allergic reagent.