Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections (Cleverin)

T

Taiko Pharmaceutical Co., Ltd.

Status

Unknown

Conditions

Respiratory Infection

Treatments

Device: Cleverin Gel
Device: Inactive Cleverin Gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT00969800
TA90811

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,469 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Triple Blind

1,469 participants in 2 patient groups

Active Cleverin Gel
Experimental group
Description:
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
Treatment:
Device: Cleverin Gel
Inactive Cleverin Gel
Sham Comparator group
Description:
Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.
Treatment:
Device: Inactive Cleverin Gel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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