UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000027776
Receipt number R000030497
Scientific Title Identification of phenotypes and endotypes by cluster analysis among patients with severe asthma in Japan
Date of disclosure of the study information 2017/07/03
Last modified on 2022/06/01 16:09:29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

National Hospital Organization Tokyo National Hospital

Institute

Department

Personal name



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

tsukahara.rie.tz@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

2022 Year 06 Month 01 Day



Link to view the page

Value
https://center6.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