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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000033971
Receipt No. R000038385
Scientific Title Three-year prognosis of clinical and molecular phenotypes among Japanese asthma patients
Date of disclosure of the study information 2018/10/01
Last modified on 2019/09/01

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Basic information
Public title Three-year prognosis of clinical and molecular phenotypes among Japanese asthma patients
Acronym 3-year prognosis in asthma phenotypes and endotypes in Japan (TNH-Azma)
Scientific Title Three-year prognosis of clinical and molecular phenotypes among Japanese asthma patients
Scientific Title:Acronym 3-year prognosis in asthma phenotypes and endotypes in Japan (TNH-Azma)
Region
Japan

Condition
Condition Asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 To clarify the differences in 3-year prognosis among asthma phenotypes by following asthma patients in Japan for 3 years.
Basic objectives2 Others
Basic objectives -Others Prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To clarify different prognosis among asthma phenotypes by comparing:
-number of acute exacerbations/year
-cumulative number of acute exacerbations
Key secondary outcomes To clarify different prognosis among asthma phenotypes by comparing:
-time to first acute exacerbation after enrollment
-respiratory function (FEV 1, %FEV1, FEV1%)
-annual change in FeNO
-annual change in asthma treatment
-annual change in ACT
-annual change in AQLQ
-annual change in ACQ
-annual change in VAS
-annual change in LCQ scores
-annual change in asthma control status (number of unscheduled visits due to asthma exacerbation, number of emergency visits, number of hospitalizations, or number of hospitalizations in ICU)

To clarify changes in asthma phenotypes in Japan within 3 years
-changes in asthma phenotypes in Japan
-phenotype change among Japanese asthma patients

To identify asthma phenotype-related genes in Japan
-differences in gene polymorphisms among asthma phenotypes

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) Asthma patients who is visiting a participating institution (asthma is defined as "diseases clinically characterized by airway narrowing (wheezing, dyspnea) or cough with chronic airway inflammation" in "Asthma Prevention and Management Guideline 2015")
(2) Patients diagnosed as asthma more than a year ago
(3) Patients older than 16 years at the time of consent
(4) Patients who provided written consent by themselves and by his guardian if he is below 20 years old
Key exclusion criteria (1) Patients using unapproved drugs such as drugs only used in clinical trials
(2) Patients judged inappropriate for participating in this study by the principal investigator/sub-investigators
Target sample size 2500

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, Center for Pulmonary Diseases
Zip code 204-8585
Address 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN
TEL 042-491-2111
Email suzukawam@tokyo-hosp.jp

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, Center for Pulmonary Diseases
Zip code 204-8585
Address 3-1-1 Takeoka, Kiyose-shi, Tokyo, 204-8585, JAPAN
TEL 042-491-2111
Homepage URL
Email suzukawam@tokyo-hosp.jp

Sponsor
Institute National Hospital Organization Tokyo National Hospital
Institute
Department

Funding Source
Organization Externally Sponsored Research(ESR-17-13158)by AstraZeneca, National Hospital Organization Tokyo National Hospital
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 institutional review board
Address 3-1-1 Takeoka, Kiyose, Tokyo, 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
2018 Year 10 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 Enrolling by invitation
Date of protocol fixation
2018 Year 08 Month 29 Day
Date of IRB
2018 Year 09 Month 29 Day
Anticipated trial start date
2018 Year 10 Month 01 Day
Last follow-up date
2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information In this study, we will compare the prognosis among asthma phenotypes in Japan based on phenotype classification collected for NHOM-Asthma. It is a novel and meaningful study.

Management information
Registered date
2018 Year 08 Month 31 Day
Last modified on
2019 Year 09 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038385

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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