UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025244
Receipt number R000029040
Scientific Title Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma
Date of disclosure of the study information 2016/12/13
Last modified on 2016/12/13 11:16:34

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Basic information

Public title

Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma

Acronym

J-Breath

Scientific Title

Multicenter trial of effectiveness and safety of bronchial thermoplasty in bronchial asthma

Scientific Title:Acronym

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

1st name
Middle name
Last name Takehiro Izumo

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-3400-1311

Email

drtake1118@gmail.com


Public contact

Name of contact person

1st name
Middle name
Last name Takehiro Izumo

Organization

Japanese Red Cross Medical Center

Division name

Respiratory Medicine

Zip code


Address

4-1-22, Hiroo, Shibuya-ku, Tokyo, Japan

TEL

03-3400-1311

Homepage URL


Email

drtake1118@gmail.com


Sponsor or person

Institute

Japanese Red Cross Medical Center

Institute

Department

Personal name



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)



IRB Contact (For public release)

Organization


Address


Tel


Email



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


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

Open public recruiting

Date of protocol fixation

2016 Year 11 Month 17 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029040


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name