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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00969800
Acronym
Cleverin
Enrollment
1469
Registered
2009-09-01
Start date
2009-10-31
Completion date
2010-04-30
Last updated
2010-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Infection

Keywords

Common cold, Influenza, Pneumonia

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.

Interventions

DEVICECleverin Gel

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

DEVICEInactive Cleverin Gel

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

Sponsors

Taiko Pharmaceutical Co., Ltd.
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
The number of incidence of respiratory infectionsFour months

Secondary

MeasureTime frame
The incidence of adverse effectsFour months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026