Povidone-iodine nasal spray (Nasodine^®) for the common cold: a randomized, controlled, double-blind, Phase III clinical trial.

IF 3.1 3区医学 Q1 MEDICINE, GENERAL & INTERNAL

Frontiers in Medicine Pub Date : 2025-06-05 eCollection Date: 2025-01-01 DOI:10.3389/fmed.2025.1565069

Thomas M Polasek, Peter L Friedland

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引用次数: 0

Abstract

Aim: To determine the safety and efficacy of a 0.5% povidone-iodine nasal spray (Nasodine) as a treatment for the common cold (ACTRN12619000764134).

Methods: A multi-center, randomized, controlled, double-blind Phase III study was conducted to assess the impact of Nasodine on the common cold. Two hundred and sixty (260) euthyroid adults with qualifying cold symptoms and meeting inclusion/exclusion criteria were randomized 2:1 to Nasodine or matching saline nasal spray (SNS), each applied 4 times daily for 5 days. Cold severity was reported using the WURSS-21 survey. The primary endpoint was impact on nasal symptoms (4-item scale), with the validated 19-item Global Severity Score (GSS) as the key secondary endpoint.

Results: All cold severity outcomes pointed in favor of Nasodine over SNS. In the ITT (n = 260), the Nasodine benefit over SNS on nasal symptoms was 8.4% (p = 0.217). For GSS, the benefit was 12.6% (p = 0.054) in the ITT population. Post hoc subset analyses showed markedly improved benefits of Nasodine: In subjects with stronger symptoms at enrollment (ES), the GSS benefit was 17.1% (p = 0.023); for those with confirmed viral infection (VES), GSS benefit was 23.0% (p = 0.048); and for those enrolled within 24 h of symptom onset (24S), GSS benefit was 39.7% (p = 0.024). In terms of functional impairment, the Nasodine benefit was greater in all subsets, with 16.1% (p = 0.041) benefit in ITT, 22.2% in ES (p = 0.012), 32.1% in VES (p = 0.023) and 37.1% in 24S (p = 0.093). Nasodine was well tolerated, with mild transient nasopharyngeal discomfort being a common adverse effect.

Conclusion: Nasodine treatment had a consistently positive and clinically meaningful benefit on overall cold severity when compared with saline nasal spray. Early treatment after symptom onset is an important efficacy factor.

Clinical trial registration: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377353&isReview=true, identifier ACTRN12619000764134.

查看原文本刊更多论文

聚维酮碘鼻喷雾剂（纳索定®）用于普通感冒：一项随机、对照、双盲、III期临床试验。

目的：确定0.5%聚维酮碘鼻喷雾剂（Nasodine）治疗普通感冒（ACTRN12619000764134）的安全性和有效性。方法：采用多中心、随机、对照、双盲III期研究，评估纳索定对普通感冒的影响。260名符合感冒症状并符合纳入/排除标准的甲状腺功能正常的成年人被随机分为2:1使用那索定或匹配的生理盐水鼻喷雾剂，每天使用4次，持续5天。使用wwurss -21调查报告感冒严重程度。主要终点是对鼻腔症状的影响（4项量表），验证的19项全球严重程度评分（GSS）是关键的次要终点。结果：所有感冒严重程度的结果都表明纳司定优于SNS。在ITT组（n = 260）中，纳舒定对鼻部症状的改善优于SNS组（p = 0.217）。对于GSS， ITT人群的获益为12.6% （p = 0.054）。事后亚组分析显示，纳索定的获益显著提高：在入组时症状较强的受试者中，GSS获益为17.1% (p = 0.023)；确诊病毒感染（VES）的患者，GSS获益为23.0% (p = 0.048)；在症状出现24小时（24S）内入组的患者，GSS获益为39.7% （p = 0.024）。在功能损害方面，纳索定在所有亚群中的获益都更大，ITT组获益16.1% (p = 0.041)， ES组获益22.2% (p = 0.012)， VES组获益32.1% (p = 0.023)， 24S组获益37.1% （p = 0.093）。纳索定耐受性良好，轻微的短暂性鼻咽不适是常见的不良反应。结论：与生理盐水鼻喷雾剂相比，纳索定治疗对整体感冒严重程度有持续的积极和临床意义的益处。出现症状后早期治疗是重要的疗效因素。临床试验注册：https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=377353&isReview=true，标识符ACTRN12619000764134。

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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来源期刊

Frontiers in Medicine Medicine-General Medicine

CiteScore

5.10

自引率

5.10%

发文量

3710

审稿时长

12 weeks

期刊介绍： Frontiers in Medicine publishes rigorously peer-reviewed research linking basic research to clinical practice and patient care, as well as translating scientific advances into new therapies and diagnostic tools. Led by an outstanding Editorial Board of international experts, this multidisciplinary open-access journal is at the forefront of disseminating and communicating scientific knowledge and impactful discoveries to researchers, academics, clinicians and the public worldwide. In addition to papers that provide a link between basic research and clinical practice, a particular emphasis is given to studies that are directly relevant to patient care. In this spirit, the journal publishes the latest research results and medical knowledge that facilitate the translation of scientific advances into new therapies or diagnostic tools. The full listing of the Specialty Sections represented by Frontiers in Medicine is as listed below. As well as the established medical disciplines, Frontiers in Medicine is launching new sections that together will facilitate - the use of patient-reported outcomes under real world conditions - the exploitation of big data and the use of novel information and communication tools in the assessment of new medicines - the scientific bases for guidelines and decisions from regulatory authorities - access to medicinal products and medical devices worldwide - addressing the grand health challenges around the world