UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045784 |
|---|---|
| Receipt number | R000052033 |
| Scientific Title | Verification of allergic symptom-improving effects and adequate safety in vivo by spraying and inhaling test aerosol |
| Date of disclosure of the study information | 2022/10/28 |
| Last modified on | 2022/10/20 18:19:27 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052033
