UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035676 |
|---|---|
| Receipt number | R000040379 |
| Scientific Title | International Severe Asthma Registry |
| Date of disclosure of the study information | 2019/01/28 |
| Last modified on | 2022/04/18 13:54:59 |
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Basic information
Public title
International Severe Asthma Registry
Acronym
ISAR
Scientific Title
International Severe Asthma Registry
Scientific Title:Acronym
ISAR
Region
| Japan | Asia(except Japan) | North America |
| South America | Australia | Europe |
| Africa |
Condition
Condition
Severe Asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To ensure the care of people with severe asthma continues to improve, it is essential we have detailed information on the health and treatment of as many people with the condition as possible. The purpose of the registry is to gather this information and track the progress of patients and how well they are responding to treatment. Medical research using data from the registry will give us a better understanding of asthma and help us develop and improve the care and treatment for patients with asthma.
Basic objectives2
Others
Basic objectives -Others
-Date of birth, gender, race, height, weight, occupation, history of bronchial thermoplasty.
-History of exacerbation, smoking
-Complications
-Blood test
-Imaging
-Pulmonary function test
-Bronchial hypersensitivity
-Exhaled nitric oxide
-Allergen
-Asthma control
-Asthma medication
-Adherence
-External contributing factors
-Future control plan
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The outcome of the registry is to proove detailed information on the health and treatment of patients with severe asthma; to track how well patients are responding to treatment; and to undertake medical research using data from the registry to improve asthma treatment and care.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. On GINA Step 5
2. Uncontrolled on GINA Step 4
Key exclusion criteria
The patients who judged with pure COPD by researcher.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tohda |
| Middle name | |
| Last name | Yuji |
Organization
Kinki-Hokuriku Airway disease conference
Division name
Kinki-Hokuriku Airway disease conference
Zip code
589-8511
Address
337-72 Onohigashi Osakasayama
TEL
072-366-0221
tohda@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Iwanaga |
Organization
Kinki-Hokuriku Airway disease conference
Division name
Kinki-Hokuriku Airway disease conference
Zip code
589-8511
Address
337-72 Onohigashi Osakasayama
TEL
072-366-0221
Homepage URL
iwanaga@med.kindai.ac.jp
Sponsor or person
Institute
Optimum Patient Care Global Limited
Institute
Department
Personal name
Funding Source
Organization
Optimum Patient Care Global Limited
Organization
Division
Category of Funding Organization
Outside Japan
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Takahashi clinic central ethics committee
Address
Medicalhatt 5-1-13 Iwayakita Nada/ku, Kobe Hyogo, Japan
Tel
078-882-6432
kishimoto.satoshi@e-smo.co.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 | 01 | Month | 28 | 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 | 11 | Month | 14 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A cohort study(from January 4, 2019).
A recruitment method of subjects : The patients who were eligible to criteria for selection.
They are under going to the medical facilities which participated in Kinki-Hokuriku airways disease conference.
Management information
Registered date
| 2019 | Year | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040379
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
