UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039409 |
|---|---|
| Receipt number | R000041825 |
| Scientific Title | registry sturdy of severe asthma |
| Date of disclosure of the study information | 2020/02/06 |
| Last modified on | 2020/02/06 15:47:34 |
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Basic information
Public title
registry sturdy of severe asthma
Acronym
registry sturdy of severe asthma
Scientific Title
registry sturdy of severe asthma
Scientific Title:Acronym
registry sturdy of severe asthma
Region
| Japan |
Condition
Condition
asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
We will centralize clinical data and materials of severe asthma patients, and make follow-up surveys every year. Then we will clarify pathophysiology of severe asthma, and make contributions to develop new therapies for asthma patients in the future.
Basic objectives2
Others
Basic objectives -Others
The lack of centralized data on severe asthma patients has resulted in a scarcity of information about the disease. In order to clarify pathophysiology and develop new therapies, registry sturdy is needed.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
annual number of exacerbations need systemic corticosteroid
Key secondary outcomes
1. lung function
2. score of questionnaries
3. prescription
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. patients who are treated with molecular target drugs, or patients who have indication for molecular target therapies.
2. severe asthma patient who need inhaled corticosteroid, long activating beta2 agonist, long activating muscarinic antagonist, leukotriene receptor antagonist, theophylline, oral corticosteroid in order to control asthma
Key exclusion criteria
patients who are considered inappropriate by the researchers
Target sample size
999
Research contact person
Name of lead principal investigator
| 1st name | Toyohiro |
| Middle name | |
| Last name | Hirai |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
606-8507
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3830
t_hirai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Hisako |
| Middle name | |
| Last name | Matsumoto |
Organization
Kyoto University
Division name
Respiratory Medicine
Zip code
606-8507
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
TEL
075-751-3830
Homepage URL
hmatsumo@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Kakenhi and Management Expenses Grants
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto university graduate school and faculty of medicine, Kyoto university hospital ethics comitte
Address
54 Kawaharamachi, Shogoin, Sakyo-ku, Kyoto City
Tel
075-753-4680
ethcom@kuhp.kyoto-u.ac.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
| 2020 | Year | 02 | Month | 06 | 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
| 2019 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 05 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is aiming to collect as much clinical data and materials of severe asthma patients as possible, and does not limit the number of registering.
We will consider the sturdy every five years, but continue for many years.
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041825
