NCT00969800

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,469

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2009

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

February 4, 2010

Status Verified

February 1, 2010

Enrollment Period

5 months

First QC Date

August 30, 2009

Last Update Submit

February 2, 2010

Conditions

Respiratory Infection

Keywords

Common coldInfluenzaPneumonia

Outcome Measures

Primary Outcomes (1)

  • The number of incidence of respiratory infections

    Four months

Secondary Outcomes (1)

  • The incidence of adverse effects

    Four months

Study Arms (2)

Active Cleverin Gel

EXPERIMENTAL

Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject.

Device: Cleverin Gel

Inactive Cleverin Gel

SHAM COMPARATOR

Inactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas.

Device: Inactive Cleverin Gel

Interventions

Cleverin GelDEVICE

Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.

Also known as: ClO2 gas generator
Active Cleverin Gel
Inactive Cleverin GelDEVICE

Seemingly same chlorine dioxide gas-generating device, but no gas is generated.

Also known as: sham ClO2 gas generator
Inactive Cleverin Gel

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Those who who agrees with the aim of the study

You may not qualify if:

  • Those who do not agree with the aim of the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Reifuen Nursing Home

Osaka, Osaka, 558-0054, Japan

Location

MeSH Terms

Conditions

Respiratory Tract InfectionsCommon ColdInfluenza, HumanPneumonia

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesPicornaviridae InfectionsRNA Virus InfectionsVirus DiseasesOrthomyxoviridae InfectionsLung Diseases

Study Officials

  • Norio Ogata, MD, PhD

    Taiko Pharmaceutical Co., Ltd.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 30, 2009

First Posted

September 1, 2009

Study Start

October 1, 2009

Primary Completion

March 1, 2010

Study Completion

April 1, 2010

Last Updated

February 4, 2010

Record last verified: 2010-02

Locations

JP(1)