New medical technologies in cough therapy: results of a double-blind randomized placebo-controlled multicenter clinical trial

Pub Date : 2024-07-07 DOI:10.26442/00403660.2024.06.202804
E. A. Polyakova, S. E. Ushakova, S. Okovityy, A. Zaytsev, M. I. Bagaeva
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Abstract

Aim. To study the efficacy and safety of Eladis® in comparison with placebo in patients with non-productive cough. Materials and methods. A phase III clinical trial enrolled 250 patients aged 18–65 years with acute respiratory viral infection with upper respiratory tract involvement or acute bronchitis. Patients were randomized into 2 groups of 125 subjects: group 1 received Eladis® (40 mg tablets), group 2 received a matching placebo. The patients received the study drugs 1 tablet BID for 7–14 days. After the treatment, patients were followed up (day 7±2) to assess the effect of therapy on the frequency of coughing attacks, the frequency and severity of daytime and nocturnal cough, the severity of cough, the duration of clinical cough cure, and the effect on the severity of the main acute respiratory viral infection symptoms. Results and conclusion. The results of the study demonstrate the overall efficacy and statistically significant superiority of Eladis® over placebo: there were significant differences between the study groups in the proportion of patients who decreased the coughing attack frequency by ≥50% by day 5 (p0.0001). In addition, the clinical cure of cough in the Eladis® group occurred 2 days earlier: the median time was 6 days, vs 8 days in placebo group. There was a decrease in the frequency of cough attacks and a decrease in its severity by more than 3.5 points by day 5 of treatment. All the effects were associated with high safety of the drug.
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咳嗽治疗中的新医疗技术:双盲随机安慰剂对照多中心临床试验结果
目的研究 Eladis® 与安慰剂相比,对无痰咳嗽患者的疗效和安全性。材料和方法。一项 III 期临床试验招募了 250 名年龄在 18-65 岁之间、患有上呼吸道急性病毒感染或急性支气管炎的患者。患者被随机分为两组,每组 125 人:第一组接受易拉迪®(40 毫克片剂),第二组接受相同的安慰剂。患者每日服用1片研究药物,连续服用7-14天。治疗后,对患者进行随访(第 7±2 天),以评估治疗对咳嗽发作频率、白天和夜间咳嗽的频率和严重程度、咳嗽的严重程度、临床咳嗽治愈时间以及对主要急性呼吸道病毒感染症状严重程度的影响。结果和结论。研究结果表明,艾拉迪斯®的总体疗效和统计学上的显著优于安慰剂:在第5天时,咳嗽发作频率减少≥50%的患者比例在研究组之间存在显著差异(P0.0001)。此外,艾乐迪®组患者的咳嗽临床治愈时间提前了2天:中位时间为6天,而安慰剂组为8天。治疗第 5 天时,咳嗽发作频率减少,严重程度降低了 3.5 个百分点以上。所有这些效果都与药物的高安全性有关。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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