Mizolastine is a new, nonsedating antihistamine providing satisfactory
symptom relief in allergic conditions. The purpose of this study was
to determine whether the onset of hay fever symptoms could be delayed
in patients known to suffer seasonal allergic rhinoconjunctivitis symp
toms if mizolastine was given before the pollen season. This double-bl
ind study involved 342 patients, randomly allocated to once-daily 10 m
g mizolastine (n = 115), once-daily 120 mg terfenadine (n = 116), or p
lacebo (n = 111) groups. All patients started treatment on 1 May, befo
re the onset of the grass pollen season. The prophylactic effect of te
st drugs was assessed on their ability to delay the time to the first
hay fever crisis of the season, which was defined by the occurrence of
one of the following events: use of rescue medication, study withdraw
al because of treatment failure, or total diary symptom score over 18.
Active treatments prolonged the time to the first crisis by approxima
tely 1 week (mizolastine 55 days, terfenadine 57 days) in comparison w
ith placebo (50 days) (survival curve analysis: Logrank test, P = 0.01
; Wilcoxon test, P = 0.03). Tolerability was satisfactory and comparab
le between groups. Thus, mizolastine can be safely used to delay and t
o treat symptoms of seasonal allergic rhinitis.