UMIN-CTR Clinical Trial

Basic information
Public title	Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma
Acronym	Prospective observational study for exploring biomarkers of bronchial thermoplasty
Scientific Title	Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma
Scientific Title:Acronym	Prospective observational study for exploring biomarkers of bronchial thermoplasty
Region	Japan

Condition
Condition	Bronchial asthma
Classification by specialty	Pneumology Clinical immunology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Exploring biomarkers of bronchial thermoplasty in bronchial asthma by the method of omics approach
Key secondary outcomes	Unexpected visits and admission for exacerbation of bronchial asthma Change of bronchial asthma related quality of life, spirometry parameters and fractional exhaled nitric oxide

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) Previously treated over a year after diagnosis of bronchial asthma 2) Bronchial asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid and long acting beta2 agonist, Willingness and ability to bronchial thermoplasty 3) Permit the other medication in combination such as anti-leukotriene antagonists, xanthine derivatives, omalizumab and systemic corticosteroids within 10 mg/day, expectorants 4) Adequate organ functions 5) Life expectancy more than a year 6) Willingness and ability to give written informed consent
Key exclusion criteria	1) Implantation of an internal or external pacemaker or internal cardiac defibrillator 2) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines 3) lower respiratory tract infection 4) Unstable asthma with an increased does of systemic corticosteroids within 2 weeks 5) Known coagulopathy 6) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDs before the procedure with physician guidance 7) Any other condition, which in the opinion of the investigator would preclude participation in the study
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hiroaki Middle name Last name Tsurumaki
Organization	Gunma University Hospital
Division name	Division of Allergy and Respiratory Medicine
Zip code	371-8511
Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
TEL	027-220-8130
Email	m12702056@gunma-u.ac.jp

Public contact
Name of contact person	1st name Hiroaki Middle name Last name Tsurumaki
Organization	Gunma University Hospital
Division name	Division of Allergy and Respiratory Medicine
Zip code	3718511
Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
TEL	027-220-8130
Homepage URL
Email	m12702056@gunma-u.ac.jp

Sponsor
Institute	Gunma University
Institute
Department

Funding Source
Organization	non
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	Gunma University Hospital Institutional Review Board
Address	3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan
Tel	027-220-8740
Email	gunmaciru-office@umin.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	群馬大学医学部附属病院(群馬県)/Gunma University Hospital(Gunma)

Other administrative information
Date of disclosure of the study information	2017 Year 02 Month 20 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	3
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	2017 Year 02 Month 01 Day
Date of IRB	2017 Year 01 Month 26 Day
Anticipated trial start date	2017 Year 02 Month 01 Day
Last follow-up date	2021 Year 01 Month 31 Day
Date of closure to data entry	2021 Year 02 Month 19 Day
Date trial data considered complete	2021 Year 02 Month 19 Day
Date analysis concluded	2021 Year 02 Month 19 Day

Other
Other related information	Study design; Prospective observational study Registration: February. 2016 to January. 2020, compatible with inclusion criteria. Using blood sample and exhaled breath condensate, any biomarkers before and after bronchial thermoplasty are measured. We explore biomarkers predictive for clinical efficacy in a year after bronchial thermoplasty.

Management information
Registered date	2017 Year 02 Month 16 Day
Last modified on	2021 Year 02 Month 19 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000030038