UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059420 |
|---|---|
| Receipt number | R000067955 |
| Scientific Title | A clinical study evaluating the symptoms of cedar pollen allergy indoor environments using nano-sized electrostatic atomized water particles (NEAWPs) |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 14:56:13 |
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Basic information
Public title
A clinical study evaluating the symptoms of cedar pollen allergy indoor environments using nano-sized electrostatic atomized water particles (NEAWPs)
Acronym
A clinical study evaluating the symptoms of cedar pollen allergy indoor environments using nano-sized electrostatic atomized water particles (NEAWPs)
Scientific Title
A clinical study evaluating the symptoms of cedar pollen allergy indoor environments using nano-sized electrostatic atomized water particles (NEAWPs)
Scientific Title:Acronym
A clinical study evaluating the symptoms of cedar pollen allergy indoor environments using NEAWPs
Region
| Japan |
Condition
Condition
Cedar pollinosis
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate changes in symptoms of cedar pollen allergy in indoor environment following the operation of NEAWPs generator device.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Nasal symptoms, frequency of sneezing, and amount of nasal discharge
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Stay in rooms equipped with NEAWPs-generating devices.
Interventions/Control_2
Stay in rooms equipped with sham devices.
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Aged 18 years or older but under 65 at the time of consent.
2. Have experienced typical symptoms of Japanese cedar pollinosis (sneezing, nasal discharge, nasal congestion, etc.) during the cedar pollen season for the past two years.
3. Have received a thorough explanation of the study, fully understood its details, and provided written consent of their own free will.
Key exclusion criteria
1. pregnant women, those who may be pregnant, or those who are breastfeeding.
2. Individuals who do not exhibit subjective symptoms or adverse events.
3. Individuals deemed unsuitable as study participants by the researchers.
4. Employees of Panasonic Corporation or its affiliated companies.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Yoshimas |
| Middle name | |
| Last name | Imoto |
Organization
University of Fukui
Division name
Department of Otorhinolaryngology Head and Neck Surgery
Zip code
910-1193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8407
yimoto@u-fukui.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sonoda |
Organization
University of Fukui
Division name
Department of Otorhinolaryngology Head and Neck Surgery
Zip code
910-1193
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
TEL
0776-61-8407
Homepage URL
kama@u-fukui.ac.jp
Sponsor or person
Institute
University of Fukui
Institute
Department
Personal name
Funding Source
Organization
Panasonic HX Living appliances and solutions company
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
Department of Otorhinolaryngology, Head & Neck Surgery, University of Fukui
Address
23-3, Shimoaizuki, Matsuoka, Eiheiji, Yoshida, Fukui
Tel
0776-61-8407
kama@u-fukui.ac.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
福井大学医学部附属病院（福井県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | 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
104
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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 02 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 12 | 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
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067955
