UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Exploratory research for unknown mechanism of bronichial thermoplasty in difficult asthma.
Title of the study (Brief title)	Exploratory research for a mechanism of bronichial thermoplasty.
Region	Japan

Condition
Condition	Difficult Asthma
Classification by specialty	Pneumology Infectious disease
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the target molecule related to the regulatory signal of BT in airway remodeling and explore the unknown mechanism of BT in defficult asthma.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Detection of target molecules on BT
Key secondary outcomes	Effect of BT, Safety of BT, quality of life, physical activity

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	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients will be eligible for inclusion in this study if all of the following criteria are met: 1.Patients with symptoms such as paroxysmal wheezing, cough, dyspnoea, etc., who are diagnosed with asthma based on a significant airway reversibility and / or airway hyperresponsiveness 2.Patients with step3 or 4 in asthma treatment by JGL 3.Patients are stable for at least 2 weeks prior to this study and can safely receive fiberoptic bronchoscopy. 4.Patients whose age is over 20 on informed consent acquisition date 5.Male and Female 6.Patients received an explanation of the study protocol and gave written informed consent. 7.Subjects are regardless of inpatients or outpatients.
Key exclusion criteria	Patients will be excluded in this study if any of the following criteria exist: 1.Patients have had an exacerbation for 2 weeks prior to this study and have been changed therapeutic strategy in stable status. 2.Patients judged as poor adherence to therapy.(ASK20 is used to assess it) 3.Patients are inadequate to include in this study.(EX: complication of malignant tumor).
Target sample size	20

Research contact person
Name of lead principal investigator	Tsunahiko Hirano
Organization	Yamaguchi University Hospital
Division name	Respiratory Medicine and Infectious Disease
Address	1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL	0836-85-3123
Email	tsuna@yamaguchi-u.ac.jp

Public contact
Name of contact person	Tsunahiko Hirano
Organization	Yamaguchi University Hospital
Division name	Respiratory Medicine and Infectious Disease
Address	1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL	0836-85-3123
Homepage URL
Email	tsuna@yamaguchi-u.ac.jp

Sponsor
Institute	Yamaguchi University Hospital Respiratory Medicine and Infectious Disease
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
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	山口大学医学部附属病院（山口県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 29 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 07 Month 27 Day
Anticipated trial start date	2016 Year 10 Month 31 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	Case-referent study Recruit subjects by posters

Management information
Registered date	2016 Year 10 Month 28 Day
Last modified on	2017 Year 06 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028291