Sousa Rita, Lakha Deepak R, Brette Sandrine, Hitier Simon
Sanofi-Aventis Deutschland GmbH, Consumer Healthcare, Industriepark Hoechst, Frankfurt am Main, Germany.
Centre of Advanced Medicine in Waverley, Johannesburg, South Africa.
Pulm Ther. 2019 Dec;5(2):201-211. doi: 10.1007/s41030-019-00100-w. Epub 2019 Oct 18.
The aim of this study was to evaluate the efficacy and safety of a new hard-boiled lozenge formulation containing ambroxol 20 mg versus placebo for the relief of sore throat in patients with acute pharyngitis.
This was a phase 3, randomized, double-blind, placebo-controlled, parallel-group multicenter trial conducted between June and September 2018 in South Africa. Patients with a diagnosis of acute pharyngitis, onset ≤ 72 h, and sore throat pain of at least moderate intensity were randomized to receive either ambroxol 20 mg or placebo hard-boiled lozenges. The primary efficacy endpoint was the normalized time-weighted sum of pain intensity differences (SPID) from baseline over 3 h following administration of the first lozenge (SPID). Secondary efficacy endpoints included SPID 24 h after the first lozenge intake (SPID) and patient assessment of efficacy at 3 and 24 h after the first lozenge.
Of 422 patients from 11 centers, 390 were randomized to one of the two treatment groups (n = 196, ambroxol; n = 194, placebo) and 388 were analyzed (modified intention-to-treat). The mean ± standard deviation SPID values were -0.386 (0.259) and -0.366 (0.243) in the ambroxol and placebo groups, respectively, and the adjusted mean ± standard error SPID difference between ambroxol and placebo was -0.020 (0.025) (p = 0.443). Comparable results between treatment groups were also found for SPID and patient assessment of efficacy at 3 and 24 h after the first lozenge. The incidence of treatment-emergent adverse events (TEAEs) was similar between treatment groups (11.7% for ambroxol versus 9.3% for placebo).
Although marked pain relief was observed over the first 3 h of treatment, superiority of ambroxol 20 mg hard-boiled lozenges versus placebo was not demonstrated in this study.
NCT03583658.
Sanofi-Aventis Group.
本研究旨在评估一种含20毫克氨溴索的新型硬糖剂型与安慰剂相比，用于缓解急性咽炎患者咽痛的疗效和安全性。
这是一项3期随机双盲安慰剂对照平行组多中心试验，于2018年6月至9月在南非进行。诊断为急性咽炎、发病时间≤72小时且咽痛至少为中度的患者被随机分配接受20毫克氨溴索或安慰剂硬糖。主要疗效终点是首次服用含片后3小时内疼痛强度差异的标准化时间加权总和（SPID）。次要疗效终点包括首次服用含片后24小时的SPID以及患者在首次服用含片后3小时和24小时对疗效的评估。
来自11个中心的422名患者中，390名被随机分配到两个治疗组之一（n = 196，氨溴索组；n = 194，安慰剂组），388名患者接受分析（改良意向性分析）。氨溴索组和安慰剂组的平均±标准差SPID值分别为-0.3— 86（0.259）和-0.366（0.243），氨溴索组与安慰剂组调整后的平均±标准误SPID差异为-0.020（0.025）（p = 0.443）。在首次服用含片后3小时和24小时的SPID以及患者对疗效的评估方面，治疗组之间也得到了类似的结果。治疗中出现的不良事件（TEAE）发生率在治疗组之间相似（氨溴索组为11.7%，安慰剂组为9.3%）。
尽管在治疗的前3小时观察到疼痛明显缓解，但本研究未证明20毫克氨溴索硬糖优于安慰剂。
NCT03583658。
赛诺菲-安万特集团。
