Allegra - Clinical Pharmacology

(Page 4)

Clinical Studies Seasonal Allergic Rhinitis:

Adults.

In three, 2-week, multicenter, randomized, double-blind, placebo-controlled trials in patients 12 to 68 years of age with seasonal allergic rhinitis (n=1634), fexofenadine hydrochloride 60 mg twice daily significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo. Statistically significant reductions in symptom scores were observed following the first 60 mg dose, with the effect maintained throughout the 12-hour interval.

In these studies, there was no additional reduction in total symptom scores with higher doses of fexofenadine hydrochloride up to 240 mg twice daily. In one 2-week, multicenter, randomized, double-blind clinical trial in patients 12 to 65 years of age with seasonal allergic rhinitis (n=863), fexofenadine hydrochloride 180 mg once daily significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo. Although the number of patients in some of the subgroups was small, there were no significant differences in the effect of fexofenadine hydrochloride across subgroups of patients defined by gender, age, and race.

Onset of action for reduction in total symptom scores, excluding nasal congestion, was observed at 60 minutes compared to placebo following a single 60 mg fexofenadine hydrochloride dose administered to patients with seasonal allergic rhinitis who were exposed to ragweed pollen in an environmental exposure unit. In one clinical trial conducted with ALLEGRA 60 mg capsules, and in one clinical trial conducted with ALLEGRA-D extended release tablets, onset of action was seen within 1 to 3 hours. Pediatrics. Two 2-week multicenter, randomized, placebo-controlled, double-blind trials in 877 pediatric patients 6 to 11 years of age with seasonal allergic rhinitis were conducted at doses of 15, 30, and 60 mg twice daily. In one of these two studies, conducted in 411 pediatric patients, all three doses of fexofenadine hydrochloride significantly reduced total symptom scores (the sum of the individual scores for sneezing, rhinorrhea, itchy nose/palate/throat, itchy/watery/red eyes) compared to placebo, however a dose response relationship was not seen. The 60 mg twice daily dose did not provide any additional benefit over the 30 mg twice daily dose.