UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of Biomarkers among Patients Undergoing Bronchial Thermoplasty
Acronym	Evaluation of Biomarkers among Patients Undergoing Bronchial Thermoplasty
Scientific Title	Evaluation of Biomarkers among Patients Undergoing Bronchial Thermoplasty
Scientific Title:Acronym	Evaluation of Biomarkers among Patients Undergoing Bronchial Thermoplasty
Region	Japan

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

Objectives
Narrative objectives1	elucidate the mechanisms of action of BT treatment
Basic objectives2	Others
Basic objectives -Others	elucidate the mechanisms of action of BT treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the relationships between the fluctuation of the biomarker(s) and response to BT defined by improvement in asthma quality of life
Key secondary outcomes

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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Diagnosis of severe asthma based on the criteria of the American Thoracic Society Age above 18 years Plan to undergo BT Ability to provide informed consent
Key exclusion criteria	asthma exacerbation during the prior month oral corticosteroid use greater than 30 mg/day use of immunosuppressants respiratory diseases such as emphysema use of beta-adrenergic blocking agents use of anticoagulants previous BT treatment any issue which in the opinion of the investigator might interfere with participation in this study.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Ken Middle name Last name Ohta
Organization	National Hospital Organization Tokyo National Hospital
Division name	Clinical Research Center
Zip code	240-8585
Address	3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL	042-491-2111
Email	kenohta@tokyo-hosp.jp

Public contact
Name of contact person	1st name Maho Middle name Last name Suzukawa
Organization	National Hospital Organization Tokyo National Hospital
Division name	Clinical Research Center
Zip code	240-8585
Address	3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL	042-491-2111
Homepage URL
Email	fueta-tky@umin.ac.jp

Sponsor
Institute	National Hospital Organization Tokyo National Hospital
Institute
Department

Funding Source
Organization	Boston Scientific
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	National Hospital Organization Tokyo National Hospital
Address	3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
Tel	042-491-2111
Email	goto.yumiko.zj@mail.hosp.go.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 02 Month 08 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	26
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	No longer recruiting
Date of protocol fixation	2017 Year 12 Month 27 Day
Date of IRB	2017 Year 12 Month 27 Day
Anticipated trial start date	2017 Year 12 Month 27 Day
Last follow-up date	2020 Year 08 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

A total of 20 patients undergoing BT will be recruited and prospectively followed for one year after the treatment period. Samples will be collected at each BT (at first BT, second BT at week 3 and third BT at week 6) before the procedure from the same bronchus (right B8), and biomarkers will be measured by either ELISA or multiplex bead assay. Clinical, physiologic and imaging assessment will be taken before each BT and one year after the treatment period. Airway hyperresponsiveness to methacholine (if possible) and patients' asthma control and questionnaires will be taken and patient medications as well as annualized asthma related adverse events will be collected before and one year after the treatment period.

Management information
Registered date	2018 Year 02 Month 08 Day
Last modified on	2022 Year 06 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035627