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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Taiko Pharmaceutical Co., Ltd..
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Taiko Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:
NCT00969800
First received: August 30, 2009
Last updated: February 2, 2010
Last verified: February 2010
History of Changes
  Purpose

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 Intervention
Respiratory Infection
 Device: Cleverin Gel
Device: Inactive Cleverin Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Gas
U.S. FDA Resources

Further study details as provided by Taiko Pharmaceutical Co., Ltd.:

Primary Outcome Measures:
  • The number of incidence of respiratory infections [ Time Frame: Four months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The incidence of adverse effects [ Time Frame: Four months ] [ Designated as safety issue: Yes ]

Enrollment: 1469
Study Start Date: October 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969800

Locations
Japan
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.
  More Information

No publications provided

Responsible Party: Norio Ogata, MD, PhD, Taiko Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT00969800     History of Changes
Other Study ID Numbers: TA90811
Study First Received: August 30, 2009
Last Updated: February 2, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Taiko Pharmaceutical Co., Ltd.:
Common cold
Influenza
Pneumonia

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases
Chlorine dioxide
Dental Disinfectants
 Disinfectants
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013