UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020949 |
|---|---|
| Receipt number | R000024146 |
| Scientific Title | Phenotype classification of Bronchial asthma |
| Date of disclosure of the study information | 2016/04/01 |
| Last modified on | 2023/02/14 10:42:25 |
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Basic information
Public title
Phenotype classification of Bronchial asthma
Acronym
Asthma Phenotype
Scientific Title
Phenotype classification of Bronchial asthma
Scientific Title:Acronym
Asthma Phenotype
Region
| Japan |
Condition
Condition
Phenotype classification of Bronchial asthma
Classification by specialty
| Pneumology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Cluster analysis of bronchial asthma both at excerbations and at stable states
Basic objectives2
Others
Basic objectives -Others
classify
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cluster analysis
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
A.Patients with asthma attack (n=100)
B.Patients with stable asthma (n=100)
C. Normal healthy control (n=30)
Key exclusion criteria
(1) Patients with respiratory diseases other than bronchial astma or COPD.
(2) Patients with severe liver, kidney disease, heart disease, hematologic disease, or severe complications.
(3) Patients whom doctors determined to be inappropriate as a subject.
Target sample size
230
Research contact person
Name of lead principal investigator
| 1st name | Sumi |
| Middle name | |
| Last name | Yuki |
Organization
Tokyo Medical and Dental University
Division name
Respiratory and Nervous System Science
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-3813-6111
ysumi.pulm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Sumi |
| Middle name | |
| Last name | Yuki |
Organization
Tokyo Medical and Dental University
Division name
Respiratory and Nervous System Science
Zip code
113-8519
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL
03-3813-6111
Homepage URL
ysumi.pulm@tmd.ac.jp
Sponsor or person
Institute
Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
KARIYA TOYOTA GENERAL HOSPITAL
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical and Dental University
Address
1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
Tel
03-3813-6111
info.bec@tmd.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
東京医科歯科大学医学部附属病院(東京都)、刈谷豊田総合病院(愛知県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 04 | 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
| 2016 | Year | 02 | Month | 09 | Day |
Date of IRB
| 2016 | Year | 03 | Month | 22 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient profile, physical examination, imaging tests, blood sampling results, collected lung function tests, exhaled nitric oxide concentration (FeNO) testing, the serum are collected
Management information
Registered date
| 2016 | Year | 02 | Month | 09 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024146
