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.