Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections (Cleverin)
Primary Purpose
Respiratory Infection
Status
Unknown status
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Cleverin Gel
Inactive Cleverin Gel
Sponsored by
About this trial
This is an interventional prevention trial for Respiratory Infection focused on measuring Common cold, Influenza, Pneumonia
Eligibility 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
Sites / Locations
- Reifuen Nursing Home
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Active Cleverin Gel
Inactive Cleverin Gel
Arm Description
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.
Outcomes
Primary Outcome Measures
The number of incidence of respiratory infections
Secondary Outcome Measures
The incidence of adverse effects
Full Information
NCT ID
NCT00969800
First Posted
August 30, 2009
Last Updated
February 2, 2010
Sponsor
Taiko Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00969800
Brief Title
Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections
Acronym
Cleverin
Official Title
Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
Study Type
Interventional
2. Study Status
Record Verification Date
February 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Taiko Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Infection
Keywords
Common cold, Influenza, Pneumonia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
1469 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Cleverin Gel
Arm Type
Experimental
Arm Description
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
Arm Title
Inactive Cleverin Gel
Arm Type
Sham Comparator
Arm Description
Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.
Intervention Type
Device
Intervention Name(s)
Cleverin Gel
Other Intervention Name(s)
ClO2 gas generator
Intervention Description
Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
Intervention Type
Device
Intervention Name(s)
Inactive Cleverin Gel
Other Intervention Name(s)
sham ClO2 gas generator
Intervention Description
Seemingly same chlorine dioxide gas-generating device, but no gas is generated.
Primary Outcome Measure Information:
Title
The number of incidence of respiratory infections
Time Frame
Four months
Secondary Outcome Measure Information:
Title
The incidence of adverse effects
Time Frame
Four months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norio Ogata, MD, PhD
Organizational Affiliation
Taiko Pharmaceutical Co., Ltd.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Reifuen Nursing Home
City
Osaka
ZIP/Postal Code
558-0054
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections
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