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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039409
Receipt No. R000041825
Scientific Title registry sturdy of severe asthma
Date of disclosure of the study information 2020/02/06
Last modified on 2020/02/06

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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
Email 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
Email hmatsumo@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041825

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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