CLINICAL TRIAL article
Front. Med.
Sec. Infectious Diseases: Pathogenesis and Therapy
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1565069
Povidone-iodine nasal spray (0.5% Nasodine®) for the common cold: a randomized, controlled, double-blind, Phase III clinical trial
Provisionally accepted
- 1Monash University, Melbourne, Australia
- 2University of Western Australia, Perth, Western Australia, Australia
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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: Two hundred and sixtyA 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 enrolment (ES), the GSS benefit was 17.1% (p=0.023); for those with confirmed viral infection (VES), GSS benefit was 23.0% (p=0.0482); and for those enrolled within 24 hours of symptom onset (24S), GSS benefit was 39.7% (p=0.024). In terms of functional impairment, the Nasodine benefit was greater than SNS for local symptoms 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.
Keywords: Povidone-Iodine, Upper Respiratory Tract Infections (URTIs), Nasodine, Nasal spray, Common Cold
Received: 22 Jan 2025; Accepted: 08 May 2025.
Copyright: © 2025 Polasek and Friedland. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Thomas Metodey Polasek, Monash University, Melbourne, Australia
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