UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020804 |
|---|---|
| Receipt number | R000024014 |
| Scientific Title | The relationship between the cough response to bronchoconstriction induced by the methacholine provocation using the astographmethod and cough reflex sensitivity to inhaled capsaicin in healthy subjects |
| Date of disclosure of the study information | 2016/01/30 |
| Last modified on | 2016/01/30 07:24:45 |
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Basic information
Public title
The relationship between the cough response to bronchoconstriction induced by the methacholine provocation using the astographmethod and cough reflex sensitivity to inhaled capsaicin in healthy subjects
Acronym
The relationship between the cough response to bronchoconstriction induced by the methacholine provocation and cough reflex sensitivity to inhaled capsaicin in healthy subjects
Scientific Title
The relationship between the cough response to bronchoconstriction induced by the methacholine provocation using the astographmethod and cough reflex sensitivity to inhaled capsaicin in healthy subjects
Scientific Title:Acronym
The relationship between the cough response to bronchoconstriction induced by the methacholine provocation and cough reflex sensitivity to inhaled capsaicin in healthy subjects
Region
| Japan |
Condition
Condition
cough variant asthma
Classification by specialty
| Pneumology | Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The relationship between the cough response to bronchoconstriction induced by the methacholine provocation using the astographmethod and cough reflex sensitivity to inhaled capsaicin in healthy subjects
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cough number induced by the methacholine provocation and cough reflex sensitivity to inhaled capsaicin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
day1 The measurement of cough response to bronchoconstriction induced by methacholine provocation using Astograph method
day2 The measurement of cough reflex sensitivity to inhaled capsaicin
day3 The measurement of cough response to bronchoconstriction induced by methacholine provocation using Astograph method (The confirmation of reproducibility of the cough response to bronchoconstriction induced by methacholine provocation)
The minimum interval between day1 and day3 is 7 days.
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
Subjects with non-smoker, aged over 20 years were eligible for the study.
Key exclusion criteria
Subjects were excluded if they had a history of any clinically significant respiratory disorders, tachyarrhythmia, heart failure or disorder that might put them at risk or influence the study results or their ability to participate.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Johsuke Hara |
Organization
Kanazawa University Graduate School of Medicine
Division name
Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2000
hara0728@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Johsuke Hara |
Organization
Kanazawa University Graduate School of Medicine
Division name
Respiratory Medicine, Cellular Transplantation Biology
Zip code
Address
13-1, Takara-machi, Kanazawa, Ishikawa, Japan
TEL
076-265-2000
Homepage URL
hara0728@gmail.com
Sponsor or person
Institute
Kanazawa University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Graduate School of Medicine
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
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
金沢大学附属病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 01 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 01 | 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
| 2016 | Year | 01 | Month | 30 | Day |
Last modified on
| 2016 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024014
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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