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AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial

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  • معلومة اضافية
    • بيانات النشر:
      Wiley
    • الموضوع:
      2024
    • Collection:
      Griffith University: Griffith Research Online
    • نبذة مختصرة :
      Rationale Saline nasal sprays are frequently used in the management of seasonal allergic rhinitis (SAR) for the cleansing and clearing of aeroallergens from the nasal cavity. Also using a drug-free approach, AM-301 nasal spray is forming a thin film barrier on the nasal mucosa to prevent contact with allergens, trap them, and facilitate their discharge. A clinical trial compared the efficacy, safety, and tolerability of AM-301 and saline spray in SAR. Methods A total of 100 patients were randomized 1:1 to self-administer AM-301 or saline 3 × daily for 2 weeks. Primary efficacy endpoint: reduction in mean daily reflective Total Nasal Symptom Score (rTNSS). Secondary efficacy endpoints: reduction in mean instantaneous TNSS and Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), global impression of efficacy. Safety and tolerability: adverse events, relief medication use, symptom-free days, global impression of tolerability. Results AM-301-treated patients achieved a significantly lower rTNSS than the saline group (LS square means difference −1.1, 95% CI −1.959 to −0.241, p = .013) with improvement observed across all individual nasal symptoms. Likewise, all secondary endpoints showed statistical significance in favor of AM-301; for example, quality of life was significantly improved overall (p < .001) as well as for each individual RQLQ domain. Both treatments showed similarly good safety and tolerability. With AM-301, fewer patients used relief medication and more enjoyed symptom-free days compared to saline treatment. Conclusions AM-301 was more effective than saline in improving SAR nasal symptoms and related quality of life while offering similar tolerability, demonstrating the benefits of a barrier approach. ; Full Text
    • ISSN:
      0105-4538
    • Relation:
      Allergy; Becker, S; Deshmukh, S; De Looze, F; Francardo, V; Lee, J; McGirr, A; Nathan, Z; Rook, C; Meyer, T, AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial, Allergy, 2024; https://hdl.handle.net/10072/430314
    • الرقم المعرف:
      10.1111/all.16116
    • الدخول الالكتروني :
      https://hdl.handle.net/10072/430314
      https://doi.org/10.1111/all.16116
    • Rights:
      https://creativecommons.org/licenses/by-nc-nd/4.0/ ; © 2024 The Authors. Allergy published by European Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd. This is an open access article under the terms of the Creative Commons Attribution-NonCommercial-NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non-commercial and no modifications or adaptations are made. ; open access
    • الرقم المعرف:
      edsbas.B42798EB