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 — GSP301, a nasal spray containing a fixed-dose combination of olopatadine hydrochloride/mometasone furoate, is a safe and effective treatment for reducing total nasal symptoms in patients with perennial allergic rhinitis (PAR), according to research presented at the Annual Scientific Meeting of the American College of Allergy, Asthma and Immunology, held November 15-19, 2018, in Seattle.
Investigators of this randomized, double-blind, parallel-group study (ClinicalTrials.gov Identifier: NCT02709538) sought to compare the long-term safety and efficacy outcomes of GSP301 nasal spray for patients with PAR. The study sample included 601 patients with PAR and were randomly assigned to receive twice-daily GSP301 treatments or 2 placebo formulations (pH 3.7 or 7.0) for 52 weeks. Descriptive statistics were used to analyze treatment-emergent adverse events. The researchers used a mixed-effect model to analyze repeated efficacy measures of 24-hour reflective and instantaneous Total Nasal Symptom Scores and calculate the mean change from baseline to week 52.
The authors reported >90% of patients achieved at least 75% medication compliance. Treatment with GSP301 led to statistically significant and clinically meaningful improvements in both reflective and instantaneous Total Nasal Symptom Scores (rTNSS, iTNSS) vs placebo (P <.01 for all) over the first 6 weeks. The clinical improvements were seen to the end of the 52-week treatment with GSP301 vs placebo.
The results indicated that no meaningful differences regarding safety outcomes were observed among the treatment groups. At week 52, treatment-emergent adverse events were reported in 51.7% of participants in the GSP301 group, 41.4% of the placebo pH 3.7 group, and 53.5% of the placebo pH 7.0 group. The most common adverse events included upper respiratory tract infection, headache, and epistaxis. At weeks 6 and 30, a significant improvement in reflective and instantaneous Total Nasal Symptom Scores was associated with the GSP301 treatment vs placebo (P =.001), with notable improvement in all individual symptoms (P <.05).
Long-term (52-week) use of GSP301 nasal spray to treat PAR was well tolerated and clinically effective, significantly improving nasal symptoms compared with placebo.
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Segall N, Lumry W, Prenner B, Caracta C, Tantry S. Long-term safety and efficacy of olopatadine/mometasone combination nasal spray in patients with perennial allergic rhinitis. Presented at: the Annual Scientific Meeting of the American College of Allergy, Asthma, and Immunology; November 15-19, 2018; Seattle, WA. Poster P456.