UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036912 |
|---|---|
| Receipt number | R000041600 |
| Scientific Title | The survey of elderly asthma patients in Japan. |
| Date of disclosure of the study information | 2019/05/31 |
| Last modified on | 2022/06/01 16:11:06 |
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Basic information
Public title
The survey of elderly asthma patients in Japan.
Acronym
The survey of elderly asthma patients in Japan. (JFGE-Asthma)
Scientific Title
The survey of elderly asthma patients in Japan.
Scientific Title:Acronym
The survey of elderly asthma patients in Japan. (JFGE-Asthma)
Region
| Japan |
Condition
Condition
Asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clarify features and problems of elderly asthma patients in Japan.
Basic objectives2
Others
Basic objectives -Others
Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
--Based on the data from NHOM-Asthma, identification of the difference between elderly and non-elderly asthma patients in Japan.
-difference of clinical practice for asthma and asthma control status
Key secondary outcomes
-- Based on the data from TNH-Azma, identification of the actual life pattern of elderly asthma patients in Japan.
-The actual life pattern
-- Based on the data from TNH-Azma, identification of the factor that affects pulmonary function decline among elderly asthma patients in Japan.
-FEV 1, %FEV1, FEV1%
-- Based on the data and samples from TNH-Azma, identification of the factor that affects asthma control status among elderly asthma patients in Japan.
-Number of acute asthma exacerbations.
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
Patients enrolled in NHOM-Asthma and/or TNH-Azma who provided written consent by themselves or by his guardian if he is below 20 years old.
Key exclusion criteria
Depending on exclusion criteria of NHOM-Asthma and TNH-Azma.
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN
TEL
042-491-2111
fueta-tky@umin.net
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
204-8585
Address
3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN
TEL
042-491-2111
Homepage URL
fueta-tky@umin.net
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Environmental Restoration and Conservation Agency; The Pollution Health Damage Prevention Fund, and Grant-in-Aid for Clinical Research from the National Hospital Organization.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN
Tel
042-491-2111
tsukahara.rie.tz@mail.hosp.go.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
| 2019 | Year | 05 | Month | 31 | 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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2019 | Year | 05 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The survey based on the data from NHOM-Asthma and TNH-Azma.
Management information
Registered date
| 2019 | Year | 05 | Month | 31 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041600
