UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan
Title of the study (Brief title)	A multicenter study of bronchial thermoplasty in Japan
Region	Japan

Condition
Condition	Severe asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the effectiveness and safety of bronchial thermoplasty for severe asthma in Japanese multicenter study.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	QOL (quality of life)(at 3M,6M,and 12M)
Key secondary outcomes	Asthma exacerbation Emergency room visits Unscheduled physician office visits Hospitalization frequency Hospitalizations Days missed from work/school Physician's Global Evaluation of Treatment Effectiveness (GETE) assessment Therapeutic drug use Pulmonary function Adverse events (at 3M,6M,and 12M)

Base
Study type	Interventional

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

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment Maneuver
Interventions/Control_1	bronchial thermoplasty(3 times every 3 weeks)
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	1. Uncontrolled severe asthma patients treated with high dose inhaled corticosteroid and long-acting beta2-agonists. 2. Eligible for fiberoptic bronchoscopy.
Key exclusion criteria	1. Have a pacemaker, implantable cardioverter defibrillator, or other implantable electronic device. 2. Have a known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines. 3. Have been previously treated with BT 4. Active respiratory infection 5. Asthma exacerbation or changing dose of systemic corticosteroids for asthma in the past 14 days 6. Known coagulopathy. As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDS before the procedure with physician guidance
Target sample size	200

Research contact person
Name of lead principal investigator	Yoshiki Ishii
Organization	Dokkyo Medical University Hospital
Division name	Department of Pulmonary Medicine and Clinical Immunology
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2151
Email	ishiiysk@dfokkyomed.ac.jp

Public contact
Name of contact person	Akihiro Takemasa
Organization	Dokkyo Medical University Hospital
Division name	Department of Pulmonary Medicine and Clinical Immunology
Address	880 Kitakobayashi, Mibu, Tochigi, Japan
TEL	0282-87-2151
Homepage URL
Email	takemasa@dokkyomed.ac.jp

Sponsor
Institute	Japanese study group for bronchial thermoplasty(J-brothers)
Institute
Department

Funding Source
Organization	Dokkyo Medical University Hospital
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Japanese study group for bronchial thermoplasty(J-brothers)
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 08 Month 01 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 07 Month 19 Day
Anticipated trial start date	2017 Year 08 Month 01 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 07 Month 28 Day
Last modified on	2017 Year 07 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032534