UMIN-CTR Clinical Trial

Basic information
Public title	Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Acronym	Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Scientific Title	Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Scientific Title:Acronym	Phenotypic classification of cough variant asthma / asthma using the Mostgraph
Region	Japan

Condition
Condition	Patients with cough
Classification by specialty	Medicine in general Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Perform phenotypic classification of patients with bronchial asthma complaining of cough / cough variant asthma using cluster analysis.
Basic objectives2	Others
Basic objectives -Others	Clarify the role of the Mostgraph as a biomarker in the diagnosis of bronchial asthma / cough asthma.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Phenotype classification by cluster analysis
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	16 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who visited at Ikebukuro Otani clinic and were performed general pulmonary function testing, blood examination, Mostgraph examination, and FeNO examination at the first visit.
Key exclusion criteria	(1) Patients receiving a steroid treatment (including inhalation), asthma treatments, or immunosuppressive therapy within one month. (2) Patients with lung cancer, interstitial pneumonia. (3) Patients with severe liver, kidney, heart, blood, and other diseases. (4) Patients who were judged to be inappropriate as a subject by the attending physician.
Target sample size	200

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Sumi
Organization	Tokyo Medical and Dental University
Division name	Biofunctional Informatics, School of health sciences, Faculty of Medicine.
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-3813-6111
Email	ysumi.pulm@tmd.ac.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Sumi
Organization	Tokyo Medical and Dental University
Division name	Biofunctional Informatics, School of health sciences, Faculty of Medicine.
Zip code	113-8519
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
TEL	03-3813-6111
Homepage URL
Email	ysumi.pulm@tmd.ac.jp

Sponsor
Institute	Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokyo Medical and Dental University
Address	1-5-45 Yushima, Bunkyo-ku, Tokyo, 113-8519, Japan
Tel	03-3813-6111
Email	info.bec@tmd.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	池袋大谷クリニック(東京都)

Other administrative information
Date of disclosure of the study information	2016 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	422
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	Main results already published
Date of protocol fixation	2016 Year 05 Month 18 Day
Date of IRB	2016 Year 06 Month 22 Day
Anticipated trial start date	2015 Year 04 Month 01 Day
Last follow-up date	2016 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Patient profile, the results of physical examination, imaging tests, blood examinations, mostgraph examination, lung function tests, and exhaled nitric oxide concentration (FeNO) testing will be collected.

Management information
Registered date	2016 Year 05 Month 18 Day
Last modified on	2022 Year 11 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025750