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

Not Applicable

• Conditions: Respiratory Infection
• Interventions: Device: Cleverin Gel; Device: Inactive Cleverin Gel

• Registration Number: NCT00969800
• Lead Sponsor: Taiko Pharmaceutical Co., Ltd.

Brief 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.

Study Timeline

• Study First Submitted: 2009-08-30
• Study First Submitted QC: 2009-08-30
• Study First Posted: 2009-09-01
• Study Start: 2009-10
• Status Verified: 2010-02
• Last Update Submitted: 2010-02-02
• Last Update Posted: 2010-02-04
• Primary Completion: 2010-03
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1469

Inclusion Criteria

• Those who who agrees with the aim of the study

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Active Cleverin Gel	Cleverin Gel	Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
Inactive Cleverin Gel	Inactive Cleverin Gel	Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.

Primary Outcome Measures

Name	Time	Method
The number of incidence of respiratory infections	Four months

Secondary Outcome Measures

Name	Time	Method
The incidence of adverse effects	Four months

Trial Locations

Locations (1)

Reifuen Nursing Home; 🇯🇵 Osaka, Japan