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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Respiratory Infection

Intervention / Treatment
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* Device: Cleverin Gel
* Device: Inactive Cleverin Gel


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Cleverin Gel<br>Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject. | Device: Cleverin Gel<br>* Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.<br>* Other names: ClO2 gas generator;|
| Sham Comparator: Inactive Cleverin Gel<br>Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas. | Device: Inactive Cleverin Gel<br>* Seemingly same chlorine dioxide gas-generating device, but no gas is generated.<br>* Other names: sham ClO2 gas generator;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of incidence of respiratory infections |  | Four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of adverse effects |  | Four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Common cold, Influenza, Pneumonia