UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043198 |
|---|---|
| Receipt number | R000049258 |
| Scientific Title | Safety study on inhalation of aerosolized hypochlorous acid solution |
| Date of disclosure of the study information | 2022/02/05 |
| Last modified on | 2022/02/03 14:52:39 |
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Basic information
Public title
Safety study on inhalation of aerosolized hypochlorous acid solution
Acronym
Safety study on inhalation of aerosolized hypochlorous acid solution
Scientific Title
Safety study on inhalation of aerosolized hypochlorous acid solution
Scientific Title:Acronym
Safety study on inhalation of aerosolized hypochlorous acid solution
Region
| Japan |
Condition
Condition
Healthy male/female adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the safety in vivo on continuous inhalation of aerosolized hypochlorous acid solution for 28 days.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events, and incidence rate of side effects
Key secondary outcomes
1. Questionnaire about physical condition
2. Physical measurement
3. Physiological test
4. Hematologic test
5. Blood-biochemical test
6. General urinalysis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Inhalation of aerosolized hypochlorous acid solution to the subject, for 28 days.
Interventions/Control_2
Inhalation of aerosolized tap-water to the subject, for 28 days.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Male/female subjects who are not less than 20 years old at informed consent.
(2) Subjects who can inhale the aerosolized test agent in their non-ventilating private room which is not bigger than 25.54 m2, for 8-10 hours a day during this trial.
(3) Subjects who can give informed consent to participate in this trial after being provided with an explanation of the experimental protocol detail.
Key exclusion criteria
(1) Subjects who take steadily in some kind of medicine continuously.
(2) All throughThroughout this trial, subjects who have any difficulty in refraining from inhaling the other antiseptic aerosols, which might affect the test results.
(3) Pregnant, possibly pregnant, or lactating women.
(4) Subjects with previous/present medical history of serious diseases in heart, liver, kidney and/or digestive organs.
(5) Subjects falling intowho have the habit of excessive alcohol intake.
(6) Subjects with extremely irregular eating habit, and/or irregular life rhythm including an irregular shift work or a midnight one.
(7) Subjects with drug and/or chemical allergy.
(8) Subjects who are now under the other clinical tests with some kind of medicine and/or health food, or took part in those within 28 days before this trial, or are planning to participate in those after giving informed consent to take part in this trial.
(9) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial.
(10) Males who donated their whole blood (400 mL) within the last three months to this trial.
(11) Females who donated their whole blood (400 mL) within the last four months to this trial.
(12) Males who will be collected in total of their blood (1200 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(13) Females who will be collected in total of their blood (800 mL) within the last twelve months, after adding the blood amounts planning to be sampled in this trial.
(14) Others who have been determined as ineligible for participation in this trial, according to the principal/sub investigator's opinions.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Fumiko |
| Middle name | |
| Last name | Nakamura |
Organization
CPCC Company Limited
Division name
Clinical Support Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Mitsuhiro |
| Middle name | |
| Last name | Fujimoto |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
101-0047
Address
4F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MORITOMO Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Sanwa-Uchi-Kanda Building, 3-3-5 Uchi-Kanda, Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 02 | Month | 05 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 02 | Month | 01 | Day |
Last modified on
| 2022 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049258
