- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00969800
Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections (Cleverin)
February 2, 2010 updated by: Taiko Pharmaceutical Co., Ltd.
Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
1469
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Osaka, Japan, 558-0054
- Reifuen Nursing Home
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
50 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active Cleverin Gel
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
|
Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
Other Names:
|
Sham Comparator: Inactive Cleverin Gel
Inactive Cleverin Gel is placed in a room of subject.
It does not generate chlorine dioxide gas.
|
Seemingly same chlorine dioxide gas-generating device, but no gas is generated.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The number of incidence of respiratory infections
Time Frame: Four months
|
Four months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The incidence of adverse effects
Time Frame: Four months
|
Four months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Norio Ogata, MD, PhD, Taiko Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2009
Primary Completion (Anticipated)
March 1, 2010
Study Completion (Anticipated)
April 1, 2010
Study Registration Dates
First Submitted
August 30, 2009
First Submitted That Met QC Criteria
August 30, 2009
First Posted (Estimate)
September 1, 2009
Study Record Updates
Last Update Posted (Estimate)
February 4, 2010
Last Update Submitted That Met QC Criteria
February 2, 2010
Last Verified
February 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TA90811
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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