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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active Cleverin Gel | Experimental | Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject. |
|
| Inactive Cleverin Gel | Sham Comparator | Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cleverin Gel | Device | Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The number of incidence of respiratory infections | Four months |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of adverse effects | Four months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Norio Ogata, MD, PhD | Taiko Pharmaceutical Co., Ltd. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Reifuen Nursing Home | Osaka | Osaka | 558-0054 | Japan |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D003139 | Common Cold |
| D007251 | Influenza, Human |
| D011014 | Pneumonia |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
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| Inactive Cleverin Gel | Device | Seemingly same chlorine dioxide gas-generating device, but no gas is generated. |
|
|
| D014777 |
| Virus Diseases |
| D009976 | Orthomyxoviridae Infections |
| D008171 | Lung Diseases |