UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040484 |
|---|---|
| Receipt number | R000046205 |
| Scientific Title | The causes of chronic and prolonged cough in Japan. |
| Date of disclosure of the study information | 2021/02/01 |
| Last modified on | 2023/02/09 10:49:06 |
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Basic information
Public title
The causes of chronic and prolonged cough in Japan.
Acronym
The causes of chronic and prolonged cough.
Scientific Title
The causes of chronic and prolonged cough in Japan.
Scientific Title:Acronym
The causes of chronic and prolonged cough.
Region
| Japan |
Condition
Condition
Prolonged and chronic cough
Classification by specialty
| Medicine in general | Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the causes of prolonged and chronic cough in Japan
Basic objectives2
Others
Basic objectives -Others
To investigate the treatment of real world of prolonged and chronic cough in Japan
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Prevalence of the causes of cough in the real world
Key secondary outcomes
Treatment of cough in the real world
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) ages over 16 years old
2) prolonged cough (dulation of cough 3-8 weeks) and chronic cough (dulation of cough over 8 weeks) with normal finding of chest Xp.
Key exclusion criteria
patients that each physisian considers inadequet to this study
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Ishiura |
Organization
Kansai Medical University Medical Center
Division name
Division of Respiratory Medicine
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi city, Osaka, Japan
TEL
0669921001
ishiuray@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | Ishiura |
Organization
Kansai Medical University Medical Center
Division name
Division of Respiratory Medicine
Zip code
570-8507
Address
10-15 Fumizono-cho, Moriguchi city, Osaka, Japn
TEL
0669921001
Homepage URL
ishiuray@takii.kmu.ac.jp
Sponsor or person
Institute
Division of Respiratory Medicine, Kansai Medical University Medical Center
Institute
Department
Personal name
Funding Source
Organization
Division of Respiratory Medicine, Kansai Medical University Medical Center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
JPN
Other related organizations
Co-sponsor
Japan cough Society
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Division of Respiratory Medicine, Kansai Medical University Medical Center
Address
10-15 Fumizono-cho, Moriguchi city, Osaka, Japan
Tel
0669921001
ishiuray@takii.kmu.ac.jp
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
| 2021 | Year | 02 | 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
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 02 | Month | 28 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 28 | Day |
Date analysis concluded
| 2023 | Year | 02 | Month | 28 | Day |
Other
Other related information
Obserbational study of cough in Japan
Management information
Registered date
| 2020 | Year | 05 | Month | 21 | Day |
Last modified on
| 2023 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046205
