Main idea: GSP301 was efficacious and well-tolerated for the treatment of seasonal allergic rhinitis symptoms compared with placebo, with a rapid onset of action of 15 minutes in patients aged ≥12 years.
GSP301 is an investigational fixed-dose combination nasal spray that contains the antihistamine, olopatadine hydrochloride (HCl), and the corticosteroid, mometasone furoate. The objective of the study was to evaluate the efficacy and safety of GSP301 in patients with seasonal allergic rhinitis (SAR). In this double-blind, randomized, parallel-group study, patients (aged ≥12 years) with SAR were equally randomized to intranasal GSP301 (olopatadine 665 μg and mometasone 25 μg), olopatadine HCl (665 μg), mometasone furoate (25 μg), or placebo for 14 days of twice-daily treatment.
Results: A total of 1180 patients were randomized. Over 14 days of treatment GSP301 significantly improved the symptoms of allergic rhinitis in comparison to placebo and olopatadine. It also approached statistical significance versus mometasone. Further, GSP301 significantly improved individual nasal symptoms, overall ocular symptoms, and the overall quality of life in comparison to the placebo group. The onset of action for GSP301 was observed within 15 minutes and was maintained at all subsequent time points assessed. The percentages of patients with treatment-emergent AEs treated with GSP301, olopatadine, mometasone, and placebo were 12.9, 12.5, 7.1, and 9.4%, respectively.