UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Title of the study (Brief title)	The time course of bronchoconstriction triggered cough reaction induced by Methacholine
Region	Japan

Condition
Condition	cough variant asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine using Astograph method
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The investigation for the time course of bronchoconstriction triggered cough reaction induced by Methacholine
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Device,equipment
Interventions/Control_1	day1 The measurement of cough response to bronchoconstriction induced by Methacholine using Astograph method day2 The measurement of cough response to bronchoconstriction induced by Methacholine using Astograph method (Investigation the reproducibility) In day2, we compare the concentration of lipid mediators in the exhaled breath condensate between before and after methacholine inhalation.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Male and female healthy subjects >= 20 years of age are eligible for inclusion. No symptom and history of respiratory disease, cardiovascular disease, gastrointestinal disease, hepatobiliar-pancreatic disease, endocrine and metabolic disease, hematological and malignant disease, renal disease, neuromuscular disease, collagen disease, autoimmune disease, psychosomatic and mental disorder, chronic infectious disease, obstetric and gynecological disease, urological disease, cerebral nervous disease.
Key exclusion criteria	Key exclusion criteria were: tachyarrhythmia, heart failure; women of childbearing potential or of breast-feeding; mental disorder or psychiatric symptom; several medical conditions prohibiting partitipation.
Target sample size	15

Research contact person
Name of lead principal investigator	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Email	hara0728@gmail.com

Public contact
Name of contact person	Johsuke Hara
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Division name	Department of Respiratory Medicine
Address	13-1 Takara-machi Kanazawa Ishikawa
TEL	076-265-2000
Homepage URL
Email	hara0728@gmail.com

Sponsor
Institute	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Institute
Department

Funding Source
Organization	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences, Kanazawa University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 06 Month 13 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2017 Year 06 Month 13 Day
Anticipated trial start date	2017 Year 06 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 06 Month 13 Day
Last modified on	2017 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031777