UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033971 |
|---|---|
| Receipt number | 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 | 2022/06/01 16:10:31 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
suzukawam@tokyo-hosp.jp
Sponsor or person
Institute
National Hospital Organization Tokyo National Hospital
Institute
Department
Personal name
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
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
| 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
No longer recruiting
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
| 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=R000038385
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
