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

Sponsor
Taiko Pharmaceutical Co., Ltd. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT00969800
Collaborator
(none)
1,469
Enrollment
1
Location
2
Arms
6
Duration (Months)
245.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Cleverin Gel
  • Device: Inactive Cleverin Gel
 N/A

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,

    1. 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.

Study Design

Study Type:
Interventional
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 :
Oct 1, 2009
Anticipated Primary Completion Date :
Mar 1, 2010
Anticipated Study Completion Date :
Apr 1, 2010

Arms and Interventions

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 Names:
  • 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 Names:
  • sham ClO2 gas generator

    		•

    Outcome Measures

    Primary Outcome Measures

    1. The number of incidence of respiratory infections [Four months]

    Secondary Outcome Measures

    1. The incidence of adverse effects [Four months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Reifuen Nursing Home Osaka Japan 558-0054

    Sponsors and Collaborators

    • Taiko Pharmaceutical Co., Ltd.

    Investigators

    • Principal Investigator: Norio Ogata, MD, PhD, Taiko Pharmaceutical Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00969800
    Other Study ID Numbers:
    • TA90811
    First Posted:
    Sep 1, 2009
    Last Update Posted:
    Feb 4, 2010
    Last Verified:
    Feb 1, 2010
    Keywords provided by , ,
    Common cold
    Influenza
    Pneumonia
    Additional relevant MeSH terms:
    Infections
    Communicable Diseases
    Respiratory Tract Infections
    Chlorine dioxide

    Study Results

    No Results Posted as of Feb 4, 2010