GSP301 Improves Ocular Symptoms in Seasonal Allergic Rhinitis

This article is part of Pulmonology Advisor‘s coverage of the American Academy of Allergy, Asthma & Immunology annual meeting, taking place in San Francisco, California. Our staff will report on medical research related to asthma, allergy, and other respiratory conditions, conducted by experts in the field. Check back regularly for more news from AAAAI 2019.

SAN FRANCISCO — Twice daily GSP301, a fixed-dose nasal spray containing 665 µg olopatadine hydrochloride and 25 µg mometasone furoate, offers a rapid onset of action, is well tolerated, and is associated with noticeable improvements in ocular symptoms in patients with seasonal allergic rhinitis.

These findings were presented at the 2019 Annual Scientific Meeting of the American College of Allergy, Asthma & Immunology (AAAAI) held February 22-25, 2019, in San Francisco, California.

Researchers pooled data from 2-week double-blind randomized placebo-controlled studies that randomly assigned patients with  seasonal allergic rhinitis to either twice daily GSP301, olopatadine (665 µg twice daily),  mometasone (25 µg twice daily), or placebo. The primary study outcome was onset of action, defined as the mean change from baseline in instantaneous Total Nasal Symptoms Score from 15 minutes to 4 hours after treatment vs placebo. Mixed-effect model repeated measures were used to analyze the primary outcome. In addition, the investigators evaluated average 12-hour post-treatment reflective Total Ocular Symptom Scores (rTOSS).

At 15 minutes after the first dose, an onset of action was found with GSP301 (least squares mean difference, –0.23; 95% CI, –0.41 to –0.05; P =.011). The onset of action was maintained at 9 different time points, and the researchers reported differences that were clinically meaningful (P <.001 for all). Compared with placebo, GSP301 was associated with greater improvements in rTOSS at baseline to 2-week follow-up (–0.47; 95% CI, –0.66 to –0.28; P <.001) and from baseline to each day during the studies (1-14; P <.001 for all). The investigators found a relatively low and comparable rate of treatment-emergent adverse events across all therapies.

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Reference

Prenner B, Hampel F, Fernando N, Caracta CF, Tantry SK. Rapid nasal symptom onset of action and ocular symptom relief with olopatadine/ mometasone combination nasal spray in patients with seasonal allergic rhinitis: a pooled analysis. Presented at: American Academy of Allergy, Asthma & Immunology Annual Meeting 2019; February 22-25, 2019; San Francisco, CA. Abstract 188.