UMIN-CTR Clinical Trial

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