UMIN-CTR Clinical Trial

Basic information
Public title	The effect of bronchial thermoplasty on severe asthmatic cough.
Acronym	The effect of BT on severe asthmatic cough
Scientific Title	The effect of bronchial thermoplasty on severe asthmatic cough.
Scientific Title:Acronym	The effect of BT on severe asthmatic cough
Region	Japan

Condition
Condition	Severe classical asthma, severe cough-predominant asthma, and severe cough-variant asthma
Classification by specialty	Pneumology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine the effect of bronchial thermoplasty on severe asthmatic cough.
Basic objectives2	Others
Basic objectives -Others	To investigate the mechanisms of bronchial thermoplasty on severe asthmatic cough.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The improvement of cough intensity and cough specific quality of life.
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	Uncontrolled
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Bronchial thermoplasty will be performed at 3-week intervals.
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Severe classical asthma, severe cough-predominant asthma, and severe cough-variant asthma whose asthma or cough control are poor irrespective of high dose inhaled corticosteroids (ICS).
Key exclusion criteria	Those who meet the contraindication criteria of bronchial thermoplasty.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University
Division name	Dept of Respiratory Medicine, Allergy and Clinical Immunology Graduate School of Medical Sciences
Zip code	4678601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	0528538216
Email	kaney32@med.nagoya-cu.ac.jp

Public contact
Name of contact person	1st name Yoshihiro Middle name Last name Kanemitsu
Organization	Nagoya City University
Division name	Dept of Respiratory Medicine, Allergy and Clinical Immunology Graduate School of Medical Sciences
Zip code	4678601
Address	1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL	0528538216
Homepage URL
Email	kaney32@med.nagoya-cu.ac.jp

Sponsor
Institute	Naogya City University
Institute
Department

Funding Source
Organization	Self-sustaining
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences,
Address	1 Kawasumi, Mizuho-Cho, Mizuho-Ku
Tel	0528538216
Email	kaney32@med.nagoya-cu.ac.jp

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 05 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2018 Year 03 Month 20 Day
Date of IRB	2018 Year 03 Month 19 Day
Anticipated trial start date	2018 Year 05 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2022 Year 04 Month 04 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036509