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

NCT ID: NCT00969800

Last Updated: 2010-02-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 1469 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2010-04-30

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.

Conditions

Respiratory Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Active Cleverin Gel

Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.

Group Type: EXPERIMENTAL

Cleverin Gel

Intervention Type: DEVICE

Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.

Inactive Cleverin Gel

Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.

Group Type: SHAM_COMPARATOR

Inactive Cleverin Gel

Intervention Type: DEVICE

Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Interventions

Cleverin Gel

Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.

Intervention Type: DEVICE

Inactive Cleverin Gel

Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Intervention Type: DEVICE

Other Intervention Names

ClO2 gas generator; sham ClO2 gas generator

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Taiko Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Taiko Pharmaceutical Co., Ltd.

Principal Investigators

Norio Ogata, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Taiko Pharmaceutical Co., Ltd.

Locations

Reifuen Nursing Home

Osaka, Osaka, Japan

Countries

Japan

Other Identifiers

TA90811

Identifier Type: -

Identifier Source: org_study_id