UMIN-CTR Clinical Trial

Basic information
Public title	Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol
Acronym	Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol
Scientific Title	Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol
Scientific Title:Acronym	Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol
Region	Japan

Condition
Condition	Healthy male/female adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	In order to confirm whether a spray/inhalation of the test aerosol could have allergic symptom-improving effects and adequate safety in vivo.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	JRQLQ-questionnaire scores about nasal symptoms (the total number of the points from "snivel", "sneeze", "stuffy" and "itch")
Key secondary outcomes	1. Allergy seriousness-sorting questionnaire scores about nasal symptoms (the maximum value from "sneeze frequency a day", "blow frequency a day" and "stuffy" in a life-diary record) 2. JRQLQ-questionnaire scores about eye symptoms (the total number of the points from "itch" and "watery") 3. Non-specific IgE concentration in serum 4. Specific IgE concentration (e.g., tick and house dust) in serum 5. Subjective symptoms concerning physical condition

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	Treatment
Type of intervention	Other
Interventions/Control_1	Spray/inhalation of the test aerosol to the subjects for eight weeks (not less than 4 hours, but no more than 8 hours a day).
Interventions/Control_2	Spray/inhalation of the placebo aerosol to the subjects for eight weeks (not less than 4 hours, but no more than 8 hours a day).
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	65 years-old >
Gender	Male and Female
Key inclusion criteria	(1) Male/female subjects ranging in age from 20 to 64 at informed consent. (2) Subjects fully realized that the subjects themselves must be in perennial allergic rhinitis. (3) Subjects who can spray and inhale the test aerosol in their non-ventilating private room which is not bigger than 25.54 m2, for not less than 4 hours, but no more than 8 hours a day during this trial. (4) Subjects who can avoid ventilating (except using an air-conditioner) and masking, during the spray/inhalation periods. (5) Subjects who can give informed consent to take part in this trial, after being provided with an explanation of our experimental protocol detail.
Key exclusion criteria	(1) Subjects with current/previous medical history of serious diseases in respiratory system. (2) Throughout this trial, subjects who take steadily in affecting medicines/foods/supplements. (3) Subjects being under some kind of medical treatment, or planning to be treated during this trial. (4) Subjects with previous/current medical history of serious diseases in heart, liver, kidney and/or digestive organs. (5) Subjects with excessive alcohol intake. (6) Pregnant, possibly pregnant, and lactating women. (7) Subjects having a drug/chemical allergy. (8) Subjects being under another clinical test with medicines and/or health foods, or participated in that within four weeks before this trial, or planning to take part in that after giving informed consent to participate in this trial. (9) Subjects who are planning to be treated for allergic rhinitis, and take steadily in antiallergic oral medicines, during this trial. (10) All the year around, subjects who take steadily in oral medicines, eye drops and nasal spray, corresponding to antihistamines and antiallergics. (11) Throughout this trial, subjects who have any difficulty in refraining from inhaling another antiseptic aerosol, which might affect the test results. (12) Subjects who donated their blood components and/or whole blood (200 mL) within a month to this trial. (13) Males who donated their whole blood (400 mL) within the last three months to this trial. (14) Females who donated their whole blood (400 mL) within the last four months to this trial. (15) 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. (16) 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. (17) Others who have been determined as ineligible for participation, judging from the principal/sub investigator's opinions.
Target sample size	24

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
Institute	CPCC Company Limited
Institute
Department

Funding Source
Organization	Aqueous Chlorine Dioxide Council
Organization
Division
Category of Funding Organization	Other
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 10 Month 28 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 10 Month 04 Day
Date of IRB	2021 Year 10 Month 01 Day
Anticipated trial start date	2021 Year 10 Month 28 Day
Last follow-up date	2022 Year 01 Month 31 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 10 Month 18 Day
Last modified on	2022 Year 10 Month 20 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052033