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news.Inspire Pharmaceuticals has reported the initiation of a 14-day randomized, double-blind Phase III clinical trial to evaluate epinastine nasal spray for the treatment of seasonal allergic rhinitis.
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The trial will compare 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 primary efficacy endpoint of this trial 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.
Christy Shaffer, president and CEO of Inspire, said: “We are pleased to initiate our Phase III program of epinastine nasal spray and look forward to reporting top-line results in the second quarter of 2008. We believe that epinastine has the potential to offer patients an alternative to intranasal steroids for the treatment of allergic rhinitis.”