Inspire Pharmaceuticals will begin Phase III clinical testing to evaluate an epinastine nasal spray for the treatment of seasonal allergic rhinitis (SAR).
The clinical trial is a 14-day randomized, double-blind comparison of a placebo and two concentrations of epinastine (0.1 percent and 0.15 percent ) at two different spray volumes. The study will include about 750 people who have a documented history of seasonal allergies to mountain cedar pollen.
The five parts of this trial will be conducted at nine clinical sites during the mountain cedar pollen season, which typically begins in December in south Texas.
During the 14-day trial period, researchers will be looking at the average change in the Total Nasal Symptom Score, defined as the sum of scores for runny nose, itchy nose and sneezing. Other areas of evaluation include nasal symptoms, ocular symptoms, quality of life, and safety.
Inspire President and CEO Christy L. Shaffer 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."