Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections (Cleverin)
Recruitment status was Active, not recruiting
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 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|
- The number of incidence of respiratory infections [ Time Frame: Four months ] [ Designated as safety issue: Yes ]
- The incidence of adverse effects [ Time Frame: Four months ] [ Designated as safety issue: Yes ]
|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)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969800
|Reifuen Nursing Home|
|Osaka, Japan, 558-0054|
|Principal Investigator:||Norio Ogata, MD, PhD||Taiko Pharmaceutical Co., Ltd.|