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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000036912
Receipt No. R000041600
Scientific Title The survey of elderly asthma patients in Japan.
Date of disclosure of the study information 2019/05/31
Last modified on 2019/05/31

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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
Email 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
Email fueta-tky@umin.net

Sponsor
Institute National Hospital Organization Tokyo National Hospital
Institute
Department

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
Email goto.yumiko.zj@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 Open public 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
2019 Year 05 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041600

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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