UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043535 |
|---|---|
| Receipt number | R000049579 |
| Scientific Title | Genetic analysis research in patients with asthma and chronic cough |
| Date of disclosure of the study information | 2021/03/05 |
| Last modified on | 2021/03/05 20:46:20 |
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Basic information
Public title
Genetic analysis research in patients with asthma and chronic cough
Acronym
Genetic analysis research in patients with asthma and chronic cough
Scientific Title
Genetic analysis research in patients with asthma and chronic cough
Scientific Title:Acronym
Genetic analysis research in patients with asthma and chronic cough
Region
| Japan |
Condition
Condition
asthma and chronic cough
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate genes related to pathophysiology and intractableness of asthma and chronic cough.
Basic objectives2
Others
Basic objectives -Others
To investigate genes related to small airway inflammation and capsaicin cough reflex sensitivity in patients with asthma and chronic cough.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To clarify associations between some genes and refractory asthma and chronic 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
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with asthma and chronic cough aged 20 years and above, who have been seeing their doctors for at least 1 year.
Key exclusion criteria
Patients
with asthma and chronic cough aged 19 years and below
who continued to see their doctors for less than 1 year
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Fukumitsu |
| Middle name | |
| Last name | Kensuke |
Organization
Nagoya City University
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
TEL
052-853-8216
k-fkmt@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Fukumitsu |
| Middle name | |
| Last name | Kensuke |
Organization
Nagoya City University
Division name
Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code
467-8601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
TEL
052-853-8216
Homepage URL
k-fkmt@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical research management center
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya City, Japan.
Tel
052-858-7215
clinical_research@med.nagoya-cu.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 | 03 | Month | 05 | 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
| 2020 | Year | 07 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 14 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Genes will be analyzed in university of Shizuoka.
We are preparing that this study will be held in multicenter.
Management information
Registered date
| 2021 | Year | 03 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049579
