GSP301 Nasal Spray Improves QoL Seasonal Allergic Rhinitis

This article is part of Pulmonology Advisor‘s coverage of the ACAAI 2018 meeting, taking place in Seattle, Washington. Our staff will report on medical research related to allergy, asthma, and more conducted by experts in the field. Check back regularly for more news from ACAAI 2018.

SEATTLE — Twice-daily treatment with GSP301, a fixed-dose combination nasal spray with olopatadine hydrochloride and mometasone furoate, led to significant improvements in both nasal symptoms and quality of life in patients with seasonal allergic rhinitis, according to research presented at the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology, held from November 15-19 in Seattle.

In two double-blind, randomized, phase 3 studies (Study 1: ClinicalTrials.gov Identifier: NCT02631551 and Study 2: ClinicalTrials.gov Identifier: NCT02870205), researchers evaluated the effect of twice-daily GSP301 on instantaneous and reflective Total Nasal Symptom Scores (iTNSS, secondary end point and rTNSS, primary end point) vs placebo (results presented elsewhere), and compared the efficacy and quality of life improvements of GSP301 vs placebo (results presented here).

Efficacy was evaluated via mean change from baseline in Physician-assessed Nasal Symptom Scores (PNSS), and quality of life was evaluated via mean change from baseline in Rhinoconjunctivitis Quality of Life Questionnaire with Standardized Activities (RQLQ[S]) scores. The 7 individual domains assessed were: activities, sleep, non-nasal/non-ocular symptoms, practical problems, nasal symptoms, ocular symptoms, and emotional. Mixed-effect model repeated measures were used to analyze results.

In both study 1 (n=1180) and study 2 (n=1176), participants with seasonal allergic rhinitis who were ≥12 years old were randomly assigned to one of the following treatment groups: GSP301 (olopatadine 665 µg and mometasone 25 µg twice daily), olopatadine (665 µg twice daily), mometasone (25 µg twice daily), or placebo for 14 days. 

The data showed significant improvements in all individual RQLQ(S) domains in Study 1 (P <.05 for all) with GSP301 vs placebo. Also, the GSP301 group showed significantly improved PNSS scores compared with the placebo group (mean difference, –0.82; 95% CI, –1.26 to –0.38; P <.001). In Study 2, signifiant improvements in 5 of 7 individual domains were observed. Also, a significant improvement in PNSS scores was seen with GSP301 vs placebo (mean difference –1.30; 95% CI, –1.75 to –0.85; P <.001).

The investigators concluded that “[t]wice-daily GSP301 treatment provided significant improvements in nasal symptoms and [quality of life] vs placebo and was well tolerated.”

Disclosures: The authors were clinical investigators, speakers/teachers, advisory committee members and/or employees of ALK, Amgen, AstraZeneca, Chiesi, Eli Lilly, GlaxoSmithKline, Glenmark Pharmaceuticals, Inc., Kaleo Pharmaceuticals, Merck, Novartis, Pfizer, Sanofi, Stallergenes, and/or Teva.

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Reference

Gross G, Berman G, Amar N, Caracta C, Tantry S. Seasonal allergic rhinitis nasal symptom and quality of life improvements with olopatadine/mometasone combination nasal spray. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology; November 15-19, 2018; Seattle, WA. Abstract P455.