Introduction: Allergic rhinitis (AR) is a disease which affects #x3e;24% of the population in Russia. Triamcinolone acetonide (TAA) is a corticosteroid used for treating AR. This post hoc analysis assesses the efficacy of intranasal TAA in improving perennial AR (PAR) symptom scores over 4 weeks. Methods: NASANIF (NCT03317015) was a double-blind, parallel-group, multicenter, prospective, non-inferiority, phase III clinical trial in which patients with PAR were randomized (1:1) to receive TAA or fluticasone propionate (FP) over 4 weeks. Our post hoc analysis evaluates weekly change in PAR symptoms using the reflective Total Nasal Symptom Score (rTNSS), overall and for individual symptoms (sneezing, nasal itching, rhinorrhoea, and nasal obstruction). Proportion of patients and time to achieve a ≥50 or ≥75% reduction in rTNSS were assessed. For rTNSS endpoints, a linear mixed-model methodology was used; for time-to-event endpoints, cumulative incidence functions were estimated using the Kaplan-Meier method, in the per-protocol population. Results: Of 260 patients, 128 each completed the study and were randomized to receive TAA or FP. From baseline to week 4, the changes in total rTNSS were −7.78 (95% CI: −8.1701 to −7.3967; p #x3c; 0.001) and −7.52 (−7.9053 to −7.1320; p #x3c; 0.001) for TAA and FP, respectively. Individual symptoms improved significantly from baseline. The proportion of patients achieving ≥50 and ≥75% reductions in total rTNSS was 88.0 and 67.2%, respectively in the TAA group. No significant differences were observed between the TAA and FP in any analyses. Conclusions: TAA produced effective and prolonged improvement of PAR symptoms over a 4-week treatment period.
Int Arch Allergy Immunol

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曲安奈德治疗常年性过敏性鼻炎：在俄罗斯进行的一项 III 期研究的事后疗效分析

简介：过敏性鼻炎 (AR) 是一种影响 #x3e;24% 俄罗斯人口的疾病。曲安奈德 (TAA) 是一种用于治疗 AR 的皮质类固醇。这项事后分析评估了鼻内 TAA 在 4 周内改善常年 AR (PAR) 症状评分的功效。方法：NASANIF (NCT03317015) 是一项双盲、平行组、多中心、前瞻性、非劣效性 III 期临床试验，其中 PAR 患者随机 (1:1) 接受 TAA 或丙酸氟替卡松 (FP) 治疗超过 4 周. 我们的事后分析使用反射性总鼻症状评分 (rTNSS) 评估 PAR 症状的每周变化，总体和个别症状（打喷嚏、鼻痒、流鼻涕和鼻塞）。评估了患者的比例和达到 rTNSS 减少 ≥50 或 ≥75% 的时间。对于 rTNSS 终点，使用了线性混合模型方法；对于事件发生时间终点，使用 Kaplan-Meier 方法在符合方案人群中估计累积发生率函数。结果：在 260 名患者中，有 128 人完成了研究并被随机分配接受 TAA 或 FP。从基线到第 4 周， TAA和FP，分别。个体症状较基线显着改善。在 TAA 组中，总 rTNSS 降低 ≥50% 和 ≥75% 的患者比例分别为 88.0% 和 67.2%。在任何分析中，TAA 和 FP 之间没有观察到显着差异。结论： TAA 在 4 周的治疗期内产生了有效且持久的 PAR 症状改善。Int Arch 过敏免疫