UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma
Title of the study (Brief title)	J-Breath
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	NO

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

Assessment
Primary outcomes	Incidence rate of adverse events of Grade 3 or higher onset occurring within 90 days after the final treatment
Key secondary outcomes	1. Incidence rate of adverse events of Grade 1 or higher after each treatment 2. Asthma control after each treatment (ratio of number of strokes per week, rate of unscheduled outpatient visits in 1 week (including emergency outpatient visit)) 3. Drug reduction effect after final treatment 4. Change in bronchial wall thickening after each treatment 5. Each treatment time 6. Activation count for each treatment 7. Adverse events of Grade 1 or higher from primary evaluation to 1 year after the last treatment

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	1) Patients diagnosed with bronchial asthma according to general allergy guideline 2016 2) Patients with bronchial asthma using high-dose inhaled corticosteroids and long-acting beta 2 agonists 3) Patients who obtain written consent regarding the participation of this study
Key exclusion criteria	1) Patients using a body defibrillator such as a pacemaker or ICD 2) Patients who have previously received bronchial thermoplasty (BT) 3) Patients with severe complications such as heart disease, liver disease or kidney failure 4) Patients with respiratory infection, blood coagulation disorder 5) Patients who had exacerbation of asthma or dose change of oral corticosteroids in the past 14 days 6) Patients who can not use drugs required for bronchoscopic procedures such as lidocaine, atropine, benzodiazepine type anxiolytic drugs 7) Patients with bronchial asthma-COPD overlap syndrome (ACOS) 8) Other patients judged unsuitable as subjects by doctor's judgment
Target sample size	40

Research contact person
Name of lead principal investigator	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Email	drtake1118@gmail.com

Public contact
Name of contact person	Takehiro Izumo
Organization	Japanese Red Cross Medical Center
Division name	Respiratory Medicine
Address	4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan
TEL	03-3400-1311
Homepage URL
Email	drtake1118@gmail.com

Sponsor
Institute	Japanese Red Cross Medical Center
Institute
Department

Funding Source
Organization	Japanese Red Cross Medical Center
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	2016 Year 12 Month 13 Day

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2016 Year 11 Month 17 Day
Anticipated trial start date	2016 Year 12 Month 22 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	Prospective multicenter study

Management information
Registered date	2016 Year 12 Month 13 Day
Last modified on	2016 Year 12 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029040