UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000027776
Receipt No. 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 2018/12/14

* 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
Middle name
Last name Ken Ohta
Organization National Hospital Organization Tokyo National Hospital
Division name The president of the hospital
Zip code
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
Middle name
Last name Maho Suzukawa
Organization National Hospital Organization Tokyo National Hospital
Division name Clinical Research Center, Center for Pulmonary Diseases
Zip code
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
Address
Tel
Email

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
Anticipated trial start date
2017 Year 07 Month 04 Day
Last follow-up date
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
2018 Year 12 Month 14 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


Contact us.