This trial is active, not recruiting.

Condition respiratory infection
Treatments cleverin gel, inactive cleverin gel
Sponsor Taiko Pharmaceutical Co., Ltd.
Start date October 2009
End date March 2010
Trial size 1469 participants
Trial identifier NCT00969800, TA90811


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model crossover assignment
Masking double blind (subject, caregiver, investigator)
Primary purpose prevention
Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
cleverin gel ClO2 gas generator
Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
(Sham Comparator)
Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.
inactive cleverin gel sham ClO2 gas generator
Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Primary Outcomes

The number of incidence of respiratory infections
time frame: Four months

Secondary Outcomes

The incidence of adverse effects
time frame: Four months

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
Principal investigator Norio Ogata, MD, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2010.
Information provided to ClinicalTrials.gov by Taiko Pharmaceutical Co., Ltd..