Rigel Pharmaceuticals has reported results from a comparative Phase II clinical
study of R112, a potential intranasal therapy for the treatment of allergic
rhinitis. The randomized, double-blind study compared R112 and Beconase AQ (beclomethasone)
nasal spray to placebo, over a seven-day period. Treatment with R112 failed
to show a statistically significant difference from placebo treatment in improving
nasal allergy symptoms, the study's primary endpoint. Beconase AQ was superior
to placebo treatment.
The study was conducted at 25 centers across the U.S. and enrolled 396 patients who had experienced seasonal allergic rhinitis during the summer/fall pollen season for the last two years. The primary endpoints were safety and efficacy, as measured by a total nasal symptom severity rating scale, a scale of five nasal symptoms including congestion, runny nose, sneezing, itchy nose and postnasal drip. The trial consisted of a screening period during which the patients stopped taking any allergy medications, followed by a placebo run-in period.