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临床试验/NCT00969800
NCT00969800Unknown不适用

Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections

Taiko Pharmaceutical Co., Ltd.2 个研究点 分布在 1 个国家目标入组 1,469 人开始时间: 2009年10月最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,469
试验地点
2
主要终点
The number of incidence of respiratory infections

研究概览

简要总结

This study is to test whether a chlorine dioxide gas-generating device, which releases a low concentration gas of chlorine dioxide in a sustained manner, can protect against respiratory infections in elderly individuals living in nursing homes. Such a device is used as a deodorant for normal domestic purposes. The investigators reasoned that the antiviral and antibacterial properties of chlorine dioxide might lead to a lowering in the incidence of respiratory infectious diseases. The study is designed as a randomized placebo-controlled double-blind crossover multicentre trial involving approximately 1500 subjects.

详细描述

Chlorine dioxide (ClO2), which is used as household deodorant, is a volatile gas that displays very strong oxidative activity. Indeed, the powerful oxidative activity of chlorine dioxide (Ogata, N., Biochemistry 46, 4898-4911, 2007) is responsible for its antimicrobial activity against bacteria (Benarde, M. A., et al. Appl. Mircrobiol. 15, 257-265, 1967), fungi (Morino, H., et al. Yakugaku Zasshi 127, 773-777, 2007) and viruses (Ogata, N. and Shibata, T. J. Gen. Virol. 89, 60-67, 2008). Recently, we found that the rate of absenteeism due to illness in a school was lower in classrooms where a chlorine dioxide gas-generating device was placed than in classrooms with no such device. Based upon this unexpected observation we hypothesize that chlorine dioxide gas, at a concentration low enough not to harm humans, may lower the incidence of respiratory infections by inactivating airborne microorganism within an enclosed space.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
50 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those who who agrees with the aim of the study

排除标准

  • Those who do not agree with the aim of the study

结局指标

主要结局

The number of incidence of respiratory infections

时间窗: Four months

次要结局

  • The incidence of adverse effects(Four months)

研究者

申办方类型
Industry

研究点 (2)

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