NCT00969800

Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,469 (actual)
• Sponsor: Taiko Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

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.

Conditions

• Respiratory Infection

Interventions

Type	Name	Description
DEVICE	Cleverin Gel	Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
DEVICE	Inactive Cleverin Gel	Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Timeline

• Start date: 2009-10-01
• Primary completion: 2010-03-01
• Completion: 2010-04-01
• First posted: 2009-09-01
• Last updated: 2010-02-04

Locations

1 site across 1 country: Japan