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

Respiratory Infection Clinical Trial

— Cleverin  

Official title:

Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00969800
• Other study ID #: TA90811
• Status: Active, not recruiting
• Phase: N/A
• First received: August 30, 2009
• Last updated: February 2, 2010
• Start date: October 2009
• Est. completion date: April 2010

Study information

• Verified date: February 2010
• Source: Taiko Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1469
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Infection
• Respiratory Infection
• Respiratory Tract Infections

Intervention

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

Locations

Country	Name	City	State
Japan	Reifuen Nursing Home	Osaka

Sponsors (1)

Lead Sponsor	Collaborator
Taiko Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of incidence of respiratory infections		Four months	Yes
Secondary	The incidence of adverse effects		Four months	Yes