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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000028427
Receipt No. R000032534
Scientific Title Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan
Date of disclosure of the study information 2017/08/01
Last modified on 2017/07/28

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Basic information
Public title Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan
Acronym A multicenter study of bronchial thermoplasty in Japan
Scientific Title Effectiveness and safety of bronchial thermoplasty-A multicenter study in Japan
Scientific Title:Acronym A multicenter study of bronchial thermoplasty in Japan
Region
Japan

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

Objectives
Narrative objectives1 To clarify the effectiveness and safety of bronchial thermoplasty for severe asthma in Japanese multicenter study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL (quality of life)(at 3M,6M,and 12M)
Key secondary outcomes Asthma exacerbation
Emergency room visits
Unscheduled physician office visits
Hospitalization frequency
Hospitalizations
Days missed from work/school
Physician's Global Evaluation of Treatment Effectiveness (GETE) assessment
Therapeutic drug use
Pulmonary function
Adverse events
(at 3M,6M,and 12M)

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
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment Maneuver
Interventions/Control_1 bronchial thermoplasty(3 times every 3 weeks)
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 1. Uncontrolled severe asthma patients treated with high dose inhaled corticosteroid and long-acting beta2-agonists.
2. Eligible for fiberoptic bronchoscopy.
Key exclusion criteria 1. Have a pacemaker, implantable cardioverter defibrillator, or other implantable electronic device.
2. Have a known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine, and benzodiazepines.
3. Have been previously treated with BT
4. Active respiratory infection
5. Asthma exacerbation or changing dose of systemic corticosteroids for asthma in the past 14 days
6. Known coagulopathy. As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDS before the procedure with physician guidance
Target sample size 200

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Yoshiki Ishii
Organization Dokkyo Medical University Hospital
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2151
Email ishiiysk@dfokkyomed.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Akihiro Takemasa
Organization Dokkyo Medical University Hospital
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-87-2151
Homepage URL
Email takemasa@dokkyomed.ac.jp

Sponsor
Institute Japanese study group for bronchial thermoplasty(J-brothers)
Institute
Department

Funding Source
Organization Dokkyo Medical University Hospital
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Japanese study group for bronchial thermoplasty(J-brothers)
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
2017 Year 08 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 Open public recruiting
Date of protocol fixation
2017 Year 07 Month 19 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 28 Day
Last modified on
2017 Year 07 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032534

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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