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

Email

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


Email

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

Email

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