UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033640 |
|---|---|
| Receipt number | R000038359 |
| Scientific Title | Effect of inhalation of hot humidified air on nasal environment |
| Date of disclosure of the study information | 2018/08/06 |
| Last modified on | 2019/04/02 12:23:35 |
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Basic information
Public title
Effect of inhalation of hot humidified air on nasal environment
Acronym
Effect of inhalation of hot humidified air on nasal environment
Scientific Title
Effect of inhalation of hot humidified air on nasal environment
Scientific Title:Acronym
Effect of inhalation of hot humidified air on nasal environment
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Oto-rhino-laryngology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of low temperature and humidity, and heated humidification on nasal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicator of nasal function; rhinomanometry and saccharin clearance time
Key secondary outcomes
Condition of nose; temperature and humidity in nasal cavity, rheology characteristics of nasal mucus, and the amount of bacteria
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
After exposure to 20C, 40% RH for 120 minutes, subjects use test product A. With a washout period for more than one week between the crossover, subjects use test product B after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product C after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_2
After exposure to 20C, 40% RH for 120 minutes, subjects use test product A. With a washout period for more than one week between the crossover, subjects use test product C after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product B after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_3
After exposure to 20C, 40% RH for 120 minutes, subjects use test product B. With a washout period for more than one week between the crossover, subjects use test product A after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product C after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_4
After exposure to 20C, 40% RH for 120 minutes, subjects use test product B. With a washout period for more than one week between the crossover, subjects use test product C after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product A after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_5
After exposure to 20C, 40% RH for 120 minutes, subjects use test product C. With a washout period for more than one week between the crossover, subjects use test product A after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product B after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_6
After exposure to 20C, 40% RH for 120 minutes, subjects use test product C. With a washout period for more than one week between the crossover, subjects use test product B after exposure to 20C, 40% RH for 120 minutes. With a washout period for more than one week between the crossover, subjects use test product A after exposure to 20C, 40% RH for 120 minutes.
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 59 | years-old | >= |
Gender
Male
Key inclusion criteria
1.Informed consent provided
2.Able to follow the instruction of the study team
Key exclusion criteria
1.Subjects with skin diseases at nose
2.Subjects with chronic illness related to nose
3.Subjects who have skin allergy to drugs, cosmetics, masks, and temperature
4.Subjects who participate in other research or treatment with physical loads that affect this test
5.Claustrophobic subjects
6.Subjects deemed inappropriate to participate in this study by the principle investigator
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takuya Mori |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7769
mori.takuya@kao.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yui Hirama |
Organization
Kao Corporation
Division name
Biological Science Research
Zip code
Address
2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL
+81-285-68-7828
Homepage URL
hirama.yui2@kao.com
Sponsor or person
Institute
Kao Corporation
Institute
Department
Personal name
Funding Source
Organization
Kao 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
Address
Tel
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
花王株式会社（栃木県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 08 | Month | 06 | 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
| 2018 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 07 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 04 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038359
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