دورية أكاديمية
AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial
| العنوان: | AM-301, a barrier-forming nasal spray, versus saline spray in seasonal allergic rhinitis: A randomized clinical trial |
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| المؤلفون: | Becker, Sven, Deshmukh, Sachin, De Looze, Ferdinandus, Francardo, Veronica, Lee, Jessie, McGirr, Anthony, Nathan, Zachary, Rook, Christopher, Meyer, Thomas |
| بيانات النشر: | Wiley |
| سنة النشر: | 2024 |
| المجموعة: | Griffith University: Griffith Research Online |
| الوصف: | 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 |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| تدمد: | 0105-4538 |
| العلاقة: | 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/10072/430314Test |
| DOI: | 10.1111/all.16116 |
| الإتاحة: | https://doi.org/10.1111/all.16116Test https://hdl.handle.net/10072/430314Test |
| حقوق: | https://creativecommons.org/licenses/by-nc-nd/4.0Test/ ; © 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 |
| رقم الانضمام: | edsbas.B42798EB |
| قاعدة البيانات: | BASE |
| تدمد: | 01054538 |
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| DOI: | 10.1111/all.16116 |