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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969800
Recruitment Status : Unknown
Verified February 2010 by Taiko Pharmaceutical Co., Ltd..
Recruitment status was:  Active, not recruiting
First Posted : September 1, 2009
Last Update Posted : February 4, 2010
Information provided by:
Taiko Pharmaceutical Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Respiratory Infection Device: Cleverin Gel Device: Inactive Cleverin Gel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1469 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Official Title: Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
Study Start Date : October 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Active Cleverin Gel
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
Device: Cleverin Gel
Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
Other Name: ClO2 gas generator

Sham Comparator: Inactive Cleverin Gel
Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.
Device: Inactive Cleverin Gel
Seemingly same chlorine dioxide gas-generating device, but no gas is generated.
Other Name: sham ClO2 gas generator

Primary Outcome Measures :
  1. The number of incidence of respiratory infections [ Time Frame: Four months ]

Secondary Outcome Measures :
  1. The incidence of adverse effects [ Time Frame: Four months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00969800

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Reifuen Nursing Home
Osaka, Japan, 558-0054
Sponsors and Collaborators
Taiko Pharmaceutical Co., Ltd.
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Principal Investigator: Norio Ogata, MD, PhD Taiko Pharmaceutical Co., Ltd.

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Responsible Party: Norio Ogata, MD, PhD, Taiko Pharmaceutical Co., Ltd. Identifier: NCT00969800     History of Changes
Other Study ID Numbers: TA90811
First Posted: September 1, 2009    Key Record Dates
Last Update Posted: February 4, 2010
Last Verified: February 2010
Keywords provided by Taiko Pharmaceutical Co., Ltd.:
Common cold
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Chlorine dioxide
Dental Disinfectants
Anti-Infective Agents