UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028427 |
|---|---|
| Receipt number | 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 15:22:38 |
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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
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
ishiiysk@dfokkyomed.ac.jp
Public contact
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
takemasa@dokkyomed.ac.jp
Sponsor or person
Institute
Japanese study group for bronchial thermoplasty(J-brothers)
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032534
