UMIN-CTR Clinical Trial

Basic information
Public title	The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Acronym	The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Scientific Title	The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Scientific Title:Acronym	The association of TRPV1 expression on airway inflammatory cells with the pathophysiology of asthma
Region	Japan

Condition
Condition	Asthma
Classification by specialty	Pneumology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association of TRPV1 expression on airway inflammatory cells with severe asthma
Basic objectives2	Others
Basic objectives -Others	To investigate the association of TRPV1 expression on airway inflammatory cells with capsaicin cough refex sensitivity, blood eosinophil/neutrophil counts, FeNO, and pulmonary function.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To investigate the association of TRPV1 expression on airway inflammatory cells with severe asthma
Key secondary outcomes	To investigate the association of TRPV1 expression on airway inflammatory cells with capsaicin cough refex sensitivity, blood eosinophil/neutrophil counts, FeNO, and pulmonary function.

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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Patients with asthma who underwent sputum induction test and capsaicin cough challenge test from September 2015 to March 2020. 2. Healthy subjects who participated in the study registered on the UMIN Clinical Trials Registry (Registry ID UMIN000018672).
Key exclusion criteria	None
Target sample size	90

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code	4678601
Address	1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	0528538216
Email	kaney32@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Division name	Department of Respiratory Medicine, Allergy and Clinical Immunology,
Zip code	4678601
Address	1 kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	0528538216
Homepage URL
Email	kaney32@med.nagoya-cu.ac.jp

Sponsor
Institute	Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan
Institute
Department

Funding Source
Organization	Grant-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology of the Japanese government (20K17219)
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	Nagoya City University
Address	1 kawasumi, mizuho-cho, mizuho-ku, Nagoya, Aichi, Japan
Tel	0538537215
Email	clinical_research@med.nagoya-cu.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

Other administrative information
Date of disclosure of the study information	2020 Year 06 Month 02 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	90
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	2020 Year 05 Month 15 Day
Date of IRB	2020 Year 05 Month 15 Day
Anticipated trial start date	2020 Year 05 Month 15 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Retrospective study

Management information
Registered date	2020 Year 06 Month 02 Day
Last modified on	2020 Year 06 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046372

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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