UMIN-CTR Clinical Trial

Basic information
Public title	Cluster analysis in Japanese asthma patients -Multi-institutional joint research-
Acronym	Cluster analysis in Japanese asthma patients
Scientific Title	Cluster analysis in Japanese asthma patients -Multi-institutional joint research-
Scientific Title:Acronym	Cluster analysis in Japanese asthma patients
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Medicine in general Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Cluster analysis is a method to identify clinically similar group by using various clinical indicators without arbitrariness. The aim of this study is to identify and characterize a refractory, severe group of asthma by cluster analysis. As recent novel clinical parameters, the airway inflammation markers and the parameters from forced oscillation technique are included. In addition, exacerbation or utilization of medical resources in each identified groups will be analyzed and clinically useful clustering will be pursued.
Basic objectives2	Others
Basic objectives -Others	Cluster analysis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Clustered group
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Asthma patients diagnosed by asthma specialist based on GINA guideline
Key exclusion criteria	None
Target sample size	500

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	Director
Zip code
Address	Takeoka 3-1-1, Kiyose city, Tokyo, Japan
TEL	042-491-2111
Email	kenohta@tokyo-hosp.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroyuki Nagase
Organization	Teikyo University School of Medicine
Division name	Department of Respiratory Medicine
Zip code
Address	Kaga 2-11-1, Itabashi-ku, Tokyo, Japan
TEL	03-3964-8351
Homepage URL
Email	nagaseh@med.teikyo-u.ac.jp

Sponsor
Institute	National Hospital Organization Tokyo National Hospital
Institute
Department

Funding Source
Organization	Health Labour Sciences Research Grant
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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	2014 Year 04 Month 11 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	2013 Year 09 Month 12 Day
Date of IRB	2013 Year 07 Month 24 Day
Anticipated trial start date	2014 Year 04 Month 15 Day
Last follow-up date	2036 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Clinical information (history, comorbidity, treatment, symptoms) Pulmonary function test Forced oscillation technique Total and specific IgE Airway inflammation markers

Management information
Registered date	2014 Year 04 Month 11 Day
Last modified on	2021 Year 05 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015985