(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.
Delmas et al. (Mon,) studied this question.