UMIN-CTR Clinical Trial

Basic information
Public title	Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan
Acronym	NHOM-Asthma
Scientific Title	Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan
Scientific Title:Acronym	NHOM-Asthma
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To identify phenotypes and endotypes among severe asthmatics in Japan. Also to conduct a field survey to reveal medical practice for asthma.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Phenotype classification in severe asthmatics
Key secondary outcomes	Actual clinical practice for asthma and its' control status Distribution of cluster-specific endotypes' distribution among patients with severe asthma

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 visiting study institutions. 2) Patients who developed asthma more than one year ago. 3) Age: patients aged 16 years or older at time of acquisition of informed consent. 4) Patients who provided written consents for this study by themselves. 5) With regard to "severe asthma patients", patients in the treatment step 3 or 4 in "Asthma Prevention and Management Guidelines 2015". (i.e., Treatment step 3: treatment with medium to high doses of inhaled corticosteroids plus any one or more from long-acting B2 stimulant, leukotriene receptor antagonist, theophylline and long-acting anticholinergic agent. Treatment step 4: treatment with high-dose inhaled corticosteroids plus two or more from long-acting B2 stimulant, leukotriene receptor antagonist, theophylline, long-acting muscarinic antagonist, anti-IgE antibodies and oral steroid.)
Key exclusion criteria	1) Patients for whom the principal investigator or sub-investigators decided not suitable for participation in this study.
Target sample size	2500

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Ohta
Organization	National Hospital Organization Tokyo National Hospital
Division name	The president of the hospital
Zip code	204-8585
Address	3-1-1 Takeoka, Kiyose-shi, Tokyo,204-8585, JAPAN
TEL	042-491-2111
Email	kenohta@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
Email	suzukawam@tokyo-hosp.jp

Sponsor
Institute	National Hospital Organization Tokyo National Hospital
Institute
Department

Funding Source
Organization	National Hospital Organization
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 Tokyo National Hospital
Address	3-1-1, Takeoka, Kiyose, Tokyo 240-8585, Japan
Tel	042-491-2111
Email	goto.yumiko.zj@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	2017 Year 07 Month 03 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	2017 Year 06 Month 05 Day
Date of IRB	2017 Year 02 Month 09 Day
Anticipated trial start date	2017 Year 07 Month 04 Day
Last follow-up date	2019 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Serological and urinary tests at time of registration, and a survey of control status for one year after registration are performed only in severe asthmatics.

Management information
Registered date	2017 Year 06 Month 16 Day
Last modified on	2019 Year 12 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030497

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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