Inspire initiates Ph III epinastine nose spray trial

The USA's Inspire Pharmaceuticals has initiated a Phase III trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis. The evaluation is a 14-day randomized, double-blind comparison of two concentrations of epinastine (0.1% and 0.15%) at two different spray volumes to placebo in approximately 750 subjects who have a documented history of seasonal allergic rhinitis to mountain cedar pollen.

This five-arm trial will be conducted at nine clinical sites during the mountain cedar pollen season, which typically begins in December in south Texas. The study's primary efficacy endpoint is the average change from baseline over the 14-day treatment period for the reflective Total Nasal Symptom Score, defined as the sum of scores for runny nose, itchy nose and sneezing. Several secondary endpoints will also be evaluated, including change in nasal and ocular symptoms, as well as quality-of-life parameters and safety endpoints. The firm expects to report top-line results in the second quarter of 2008.