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A double-blind, randomized, parallel-group trial with children who had seasonal allergic rhinitis sought to determine the effectiveness, safety, and tolerability of GSP301.
Intranasal use of GSP301 (1 spray/each nostril twice daily for 14 days) effectively mitigated allergic rhinitis symptoms in children aged 6-11 years.
A double-blind, randomized, parallel-group trial with children who had seasonal allergic rhinitis sought to determine the effectiveness, safety, and tolerability of GSP301.
GSP301 [665 μg Olopatadine hydrochloride and 25 μg Mometasone furoate] or placebo was administered as 1 spray in each nostril two times a day for 14 days to 446 eligible participants in a 1:1 ratio. Alteration from baseline in average evening and morning subject-reported 12-hour reflective Total Nasal Symptom Score (rTNSS) across a 14-day intervention period was the major outcome, and it was evaluated utilizing a mixed-effect model repeated measures.
Individual symptoms, the Physician- assessed Nasal Symptom Score (PNSS), the Pediatric Rhinoconjunctivitis Quality of Life Questionnaire (PRQLQ), the Instantaneous TNSS (iTNSS), the Total Ocular Symptoms Scores (rTOSS, iTOSS), and adverse events were also measured.
Compared to the placebo, GSP301 showed a statistically meaningful enhancement in rTNSS. All of the individual rTNSS symptoms, the majority of the individual iTNSS symptoms, PNSS, and PRQLQ showed clinically meaningful improvements in favor of GSP301. Only reflective "watering/tearing eyes" reached clinical significance for ocular symptoms, where there were numerical improvements favoring GSP301.
In the placebo and GSP301 groups, treatment-emergent adverse events occurred in 10.4% and 12.0% of subjects, respectively. One (0.5%) participant in the placebo group had a serious adverse event (suspected viral meningitis) that was unrelated to the study therapy and was resolved.
In pediatric patients, the fixed-dose combination of antihistamine Olopatadine hydrochloride and corticosteroid Mometasone furoate was safe, well-tolerated, and effective in alleviating seasonal allergic rhinitis symptoms.
Annals of Allergy, Asthma & Immunology
Efficacy and safety of GSP301 nasal spray in children aged 6-11 with seasonal allergic rhinitis
Bruce M. Prenner et al.
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