UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018679 |
|---|---|
| Receipt number | R000021623 |
| Scientific Title | Development of pathophysiologic diagnosis for cough variant asthma and atopic cough: retrospective cohort observational study |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2016/01/06 14:57:58 |
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Basic information
Public title
Development of pathophysiologic diagnosis for cough variant asthma and atopic cough: retrospective cohort observational study
Acronym
Pathophysiologic diagnosis of cough
Scientific Title
Development of pathophysiologic diagnosis for cough variant asthma and atopic cough: retrospective cohort observational study
Scientific Title:Acronym
Pathophysiologic diagnosis of cough
Region
| Japan |
Condition
Condition
Chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop procedure of pathophysiologic diagnosis for cough variant asthma and atopic cough on basis of measurements of cough receptor sensitivity and bronchoconstriction-triggered cough response.
Basic objectives2
Others
Basic objectives -Others
Usefullness
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To establishi the procedure of pathophysiologic diagnosis for cough variant asthma and atopic cough
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Outpatients suffering from non-productive cough for 3 weeks or more
Key exclusion criteria
Patients having significant cardiac and pulmonary disease
Patients unable to understand examinations
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaki Fujimura |
Organization
NHO Nanao Hospital
Division name
Respiratory Medicine
Zip code
Address
8 bu 3-1 Matsuto-machi, Nanao, Ishikawa, Japan
TEL
0767-53-1890
fujimura@hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Fujimura |
Organization
NHO Nanao Hospital
Division name
Respiratory Medicine
Zip code
Address
8 bu 3-1 Matsuto-machi, Nanao, Ishikawa, Japan
TEL
0767-53-1890
Homepage URL
fujimura@hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Nanao Hospital
Institute
Department
Personal name
Funding Source
Organization
National Hospital Organization Nanao Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2013 | Year | 03 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 04 | 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
Cohort study
Recruit of subjects (all patients who visit our hospital between 2013/4/1 and 2018/3/31), met the eligibility criteria, and give informed consent.
Management information
Registered date
| 2015 | Year | 08 | Month | 14 | Day |
Last modified on
| 2016 | Year | 01 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
