UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Title of the study (Brief title)	Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Region	Japan

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

Objectives
Narrative objectives1	To elucidate the efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Post BT treatment complications, therapeutic control level, pulmonary functions
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	Treatment
Type of intervention	Maneuver
Interventions/Control_1	bronchial thermoplasty
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1)Severe uncontrolled bronchial asthma on high-dose inhaled corticosteroids, which is equivalent to 1000 or more micro g/day of beclomethasone dipropionate and long-acting beta 2 agonist 2)Ability to tolerate bronchoscopy and suitable for bronchial thermoplasty 3)Aged 20 years old and older 4)Provided written informed consent to participate in the study
Key exclusion criteria	1)Malignant tumors 2)Severe heart disease 3)Severe hepatic failure 4)Severe renal failure (serum creatinine levels 2.0 or more mg/dl) 5)Current use of a body defibrillator, such as pacemaker or implantable cardioverter defibrillator 6)Active infectious disease 7)Exacerbation of asthma or change in the drug regimen to include oral corticosteroids in the past 14 days 8)Change in the maintenance drug therapy for bronchial asthma in the past 4 weeks 9)Less than 65% post-bronchodilator %FEV1 10)Uncontrolled sinusitis 11)Requirement for oral steroid that is equivalent to more than 10 mg/day of prednisone to control bronchial asthma 12)Past history of intubation or admission to the intensive care unit due to bronchial asthma in the past 24 months 13)Past history in the past 12 months as follows; i) 4 or more infections of the lower respiratory tract, or ii) 3 or more admissions due to respiratory symptoms 14)Has smoked in the past 12 months or has a smoking history of 10 or more pack-years 15)Has previously undergone bronchial thermoplasty 16)Pregnancy or potential pregnancy 17)Judged inadequate to participate in the study by their physicians
Target sample size	20

Research contact person
Name of lead principal investigator	Toshio Ichiwara
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Respiratory Medicine
Address	1163 Tatemachi Hajiojishi Tokyo
TEL	042-665-5611
Email	ichiwata@tokyo-med.ac.jp

Public contact
Name of contact person	Shinji Teramoto
Organization	Tokyo Medical University Hachioji Medical Center
Division name	Department of Respiratory Medicine
Address	1163 Tatemachi Hajiojishi Tokyo
TEL	042-665-5611
Homepage URL
Email	shinjit-tky@umin.ac.jp

Sponsor
Institute	Tokyo Medical University
Institute
Department

Funding Source
Organization	Tokyo mecical 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	2018 Year 12 Month 31 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 04 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	2018 Year 12 Month 31 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040351