Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections

Official Title: “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.

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.

Intervention(s) in this Clinical Trial

• Device: Cleverin Gel
  • Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
• Device: Inactive Cleverin Gel
  • Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Active Cleverin Gel
  • Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.
• Sham Comparator: Inactive Cleverin Gel
  • Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.

Primary Measures

• The number of incidence of respiratory infections
  • Time Frame: Four months
    Safety Issue?: Yes

Secondary Measures

• The incidence of adverse effects
  • Time Frame: Four months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Taiko Pharmaceutical Co., Ltd. Industry

Overall Clinical Trial Officials and Contacts

Norio Ogata, MD, PhD Principal Investigator Taiko Pharmaceutical Co., Ltd.  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00969800

Study ID Number: TA90811

ClinicalTrials.gov Identifier: NCT00969800

Health Authority: Japan: Ministry of Health, Labor and Welfare