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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000033640
Receipt No. R000038359
Official scientific title of the study Effect of inhalation of hot humidified air on nasal environment
Date of disclosure of the study information 2018/08/06
Last modified on 2018/08/07

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Basic information
Official scientific title of the study Effect of inhalation of hot humidified air on nasal environment
Title of the study (Brief title) 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 Takuya Mori
Organization Kao Corporation
Division name Biological Science Research
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7769
Email mori.takuya@kao.com

Public contact
Name of contact person Yui Hirama
Organization Kao Corporation
Division name Biological Science Research
Address 2606, Akabane, Ichikai-machi, haga-gun, Tochigi, 321-3497, JAPAN
TEL +81-285-68-7828
Homepage URL
Email hirama.yui2@kao.com

Sponsor
Institute Kao Corporation
Institute
Department

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)

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

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2018 Year 07 Month 18 Day
Anticipated trial start date
2018 Year 08 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038359

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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