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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000035303
Receipt No. R000040223
Scientific Title The relationship between methacholine induced cough response, cough receptor sensitivity to capsaicin and a sensation of irritation in the throat
Date of disclosure of the study information 2018/12/18
Last modified on 2018/12/18

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Basic information
Public title The relationship between methacholine induced cough response, cough receptor sensitivity to capsaicin and a sensation of irritation in the throat
Acronym The relationship between methacholine induced cough response, cough receptor sensitivity to capsaicin and a sensation of irritation in the throat
Scientific Title The relationship between methacholine induced cough response, cough receptor sensitivity to capsaicin and a sensation of irritation in the throat
Scientific Title:Acronym The relationship between methacholine induced cough response, cough receptor sensitivity to capsaicin and a sensation of irritation in the throat
Region
Japan

Condition
Condition healthy adults
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate whether the cough response induced by inhaled methacholine and cough reflex sensitivity to inhaled capsaicin are related to the degree of a sensation of irritation in the throat in healthy adult.
Basic objectives2 Others
Basic objectives -Others To investigate whether there is a difference in a sensation in the throat caused by inhaled methacholine and capsaicin.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between the cough response induced by methacholine inhalation and a sensation in the throat.
Correlation between the cough reflex sensitivity to inhaled capsaicin and a sensation in the throat.
Key secondary outcomes Difference in a sensation in the throat caused by inhaled methacholine and capsaicin.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 visit 1, 3 inhalation of methacholine
visit 2 inhalation of capsaicin
Interventions/Control_2
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

Not applicable
Gender Male and Female
Key inclusion criteria 1: subjects with aged 20 years or older
2; subjects without history of respiratory disease and symptoms
3; subjects who can get documentary consent by one's own free will after enough informed consent
4; subjects with NLHQ is less than 17.1.
Key exclusion criteria 1; subjects with cardiovascular disease, liver / biliary tree disease, digestive organ disease, immune disease or malignant tumor etc
2; subjects with a low pulmonary function whose 1 second amount is 1 L or less
3; subjects with the risk of pneumothorax and mediastinal emphysema
4: subjects who are allergic to capsaicin
5; pregnant or having a possibility of pregnancy
6; subjects who is lactating
7; Others who judged inappropriate by other research researcher or research sharing doctor
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuo Kasahara
Organization Kanazawa University Hospital
Division name Respiratory medicine
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Email hara0728@staff.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Johsuke Hara
Organization Kanazawa University Hospital
Division name Respiratory medicine
Zip code
Address 13-1, Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2000
Homepage URL
Email hara0728@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University Hospital
Institute
Department

Funding Source
Organization Kanazawa University Hospital
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
Address
Tel
Email

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
2018 Year 12 Month 18 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Open public recruiting
Date of protocol fixation
2018 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2018 Year 11 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 12 Month 18 Day
Last modified on
2018 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040223

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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