Respiratory InfectionCleverinNCT00969800
Test of a Preventive Effect of a Deodorant Device Against Respiratory Infections
A study testing Cleverin Gel and Inactive Cleverin Gel in people with Respiratory Infection, run by Taiko Pharmaceutical Co., Ltd. at 1 site in Japan.
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. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Respiratory Infection
- What is being tested?
- Cleverin Gel and Inactive Cleverin Gel
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,469 participants
- Where
- 1 siteJapan
- Study dates
- Oct 2009to Apr 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Those who who agrees with the aim of the study
Who cannot join
- Those who do not agree with the aim of the study
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Respiratory Infection
- Being tested
- Cleverin Gel, Inactive Cleverin Gel
- Keywords
- Common cold, Influenza, Pneumonia
- Medical subject headings
- Respiratory Tract Infections, Common Cold, Influenza, Human, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleverin GelDevice
Also called ClO2 gas generator
Chlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm.
Inactive Cleverin GelDevice
Also called sham ClO2 gas generator
Seemingly same chlorine dioxide gas-generating device, but no gas is generated.
| Study group | Role | What they receive |
|---|---|---|
| Active Cleverin Gel | Experimental | Active Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject. Receives: 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. Receives: Device: Inactive Cleverin Gel |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of incidence of respiratory infections
Measured: Four months
Secondary outcomes (1)
The incidence of adverse effects
Measured: Four months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2009 (estimated)
- Study startOct 2009
- Primary completionMar 2010 (estimated)
- Study completionApr 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,469 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taiko Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Norio Ogata, MD, PhD, Principal investigator, Taiko Pharmaceutical Co., Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00969800
- Sponsor's protocol ID
- TA90811
- Acronym
- Cleverin
- Status last verified
- Feb 2010
- First submitted
- 30 Aug 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Sham Device-controlled Multi-center Crossover Trial of Chlorine Dioxide Gas on the Protective Effect Against Respiratory Infections
- ClinicalTrials.gov ID
- NCT00969800
- Acronym / sponsor ID
- Cleverin / TA90811
- Conditions
- Respiratory Infection
- Keywords
- Common cold, Influenza, Pneumonia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,469 participants (actual)
- Lead sponsor
- Taiko Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Mar 2010 (estimated)
- Study completion
- Apr 2010 (estimated)
- First posted
- 1 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Cleverin Gel | Experimental | Device: Cleverin GelActive Cleverin Gel, which generates chlorine dioxide gas, is placed in a room of subject. |
| Inactive Cleverin Gel | Sham comparator | Device: Inactive Cleverin GelInactive Cleverin Gel is placed in a room of subject. It does not generate chlorine dioxide gas. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Those who who agrees with the aim of the study
Key exclusion criteria (1 listed)
- Those who do not agree with the aim of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleverin GelAlso: ClO2 gas generatorChlorine dioxide gas concentration at a range of 0.005 to 0.03 ppm. | Device | Active Cleverin Gel |
| Inactive Cleverin GelAlso: sham ClO2 gas generatorSeemingly same chlorine dioxide gas-generating device, but no gas is generated. | Device | Inactive Cleverin Gel |
Primary outcome
The number of incidence of respiratory infections
Time frame: Four months
1 secondary outcome
The incidence of adverse effects
Time frame: Four months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Norio Ogata, MD, PhD principal investigator
Taiko Pharmaceutical Co., Ltd.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cleverin Gel and Inactive Cleverin Gel in people with Respiratory Infection, run by Taiko Pharmaceutical Co., Ltd. at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of incidence of respiratory infections (time frame: Four months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2010.