A nasal spray that combines olopatadine and mometasone is safe and improves symptoms of seasonal allergic rhinitis, according to findings presented at the American Academy of Allergy, Asthma and Immunology Annual Meeting.
“Combining an intranasal antihistamine with an intranasal corticosteroid for the treatment of allergic rhinitis may provide improved symptom relief over monotherapy treatment,” Frank D. Hampel, MD, from Central Texas Health Research, and colleagues wrote.
Hampel and colleagues conducted a phase 3 study to determine the efficacy and safety of a fixed-dose nasal spray that combines the antihistamine olopatadine hydrochloride with the corticosteroid mometasone furoate, known as GSP301, for seasonal allergic rhinitis. The researchers enrolled 1,180 patients aged 12 years or older with seasonal allergic rhinitis and randomly assigned them to receive either a combination of 665 µg of olopatadine 665 µg and 25 µg of mometasone (GSP301) twice daily, 665 µg of olopatadine HCl twice daily, 25 µg of mometasone furoate twice daily or placebo twice daily for 14 days.
Data indicated that participants receiving GSP301 had significantly improved reflective total nasal symptom scores than those taking placebo (least squares mean difference, –0.98; 95% CI, –1.38 to –0.57) and olopatadine (least squares mean difference, –0.61; 95% CI, –1.01 to –0.21). Compared with mometasone, GSP301 demonstrated clinically meaningful but not quite significant improvements in reflective total nasal symptom scores (least squares mean difference, –0.39; 95% CI, –0.79 to 0.01).
Reflective total nasal symptom scores were significantly improved with mometasone monotherapy (least squares mean difference, –0.59; 95% CI, –1.00 to –0.19]; P=.004), but not with olopatadine monotherapy (least squares mean difference, –0.37; 95%CI, –0.78 to 0.04), compared with placebo.
Adverse events related to treatment were similar in the GSP301 (12.9%), olopatadine (12.5%), mometasone (7.1%) and placebo (9.4%) groups.
“In this study, twice-daily GSP301 treatment provided significant and clinically meaningful improvements in [seasonal allergic rhinitis] nasal symptoms versus placebo and was well tolerated,” Hampel and colleagues concluded. – by Alaina Tedesco