What question did this study set out to answer?

March 4, 20260 citationsOpen Access

Tolerability, Efficacy, and Quality of Life Outcomes of Allerspray-G Nasal Spray in Adults with Allergic Rhinitis: Real-World Post-Marketing Clinical Trial

MDMarine DelmasInstitut National de Recherche pour l'Agriculture, l'Alimentation et l'Environnement MDManon D’AlmeidaInstitut pour l'avancée des biosciences SDSéverine Dameron-PuechInstitut pour l'avancée des biosciences

Key Points

Evaluate the tolerability, efficacy, and quality of life outcomes of Allerspray-G in adults with allergic rhinitis.
Open-label, single-center design
Real-world post-marketing evaluation
Assessment of adverse events for tolerability
Total Nasal Symptom Score used for efficacy measures
Patient-reported quality of life outcomes assessed
20% reported mild adverse events related to Allerspray-G
Total Nasal Symptom Score decreased significantly (mean change: -1.94, p < 0.001)
73.3% of participants achieved a ≥30% reduction in TNSS
Significant improvements noted in quality of life (p < 0.05)

Abstract

(1) Allergic rhinitis (AR) is a chronic inflammatory condition of nasal mucosa that impairs quality of life (QOL). Beyond pharmacological treatments, some patients seek non-pharmacological options due to side effects or incomplete symptom control. Allerspray-G (AAG) is a barrier-forming Class IIa medical device (Medical Device Regulation (MDR) 2017/745) designed to reduce allergen contact and alleviate AR symptoms. This study evaluated the safety and efficacy of AAG in adults with AR in a real-life post-marketing setting through an open-label, single-center investigation using a two-stage Fleming design. (2) Tolerance was the primary outcome, assessed through the monitoring of adverse events. Secondary outcomes included efficacy measures, evaluated using the Total Nasal Symptom Score (TNSS) and patient-reported QOL outcomes. (3) In total, 20% reported a possible or probable event related to AAG, with all being mild. The TNSS decreased significantly from baseline (mean change: −1.94, p < 0.001), and 73.3% achieved a ≥30% reduction. Significant improvements were also observed across all QOL domains (p < 0.05). (4) AAG was safe, well tolerated, and improved nasal symptoms and QOL, supporting its use as a non-pharmacological option for symptom relief in allergic rhinitis. These findings are consistent with and further reinforce results from the initial 2017 clinical study.

اسأل الذكاء الاصطناعي

Bookmark

View Full Paper