UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028391 |
|---|---|
| Receipt number | R000032501 |
| Scientific Title | Effectiveness and safety of bronchial thermoplasty multicenter study in Japan |
| Date of disclosure of the study information | 2017/07/29 |
| Last modified on | 2023/01/29 09:22:06 |
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Basic information
Public title
Effectiveness and safety of bronchial
thermoplasty multicenter study in Japan
Acronym
Bronchial thermoplasty multicenter study
in Japan
Scientific Title
Effectiveness and safety of bronchial
thermoplasty multicenter study in Japan
Scientific Title:Acronym
Bronchial thermoplasty multicenter study
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 ofbronchial thermoplasty for severe asthma
in Japanese multicenter study.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
QOL (quality of life)
Key secondary outcomes
1.Asthma exacerbation
2.Emergency room visits
3.Unscheduled physician office visits
4.Hospitalization frequency
5.Hospitalizations
6.Days missed from work/school
7.Physician's Global Evaluation of
Treatment Effectiveness (GETE)
assessment
8.Therapeutic drug use
9.Pulmonary function
10.Adverse events
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
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 doseof 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 | Akihiro |
| Middle name | none |
| Last name | Takemasa |
Organization
Dokkyo Medical University School of
Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282861111
takemasa@dokkyomed.ac.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | none |
| Last name | Takemasa |
Organization
Dokkyo Medical University School of Medicine
Division name
Department of Pulmonary Medicine and Clinical Immunology
Zip code
3210293
Address
880 Kitakobayashi, Mibu, Tochigi
TEL
0282861111
Homepage URL
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000032501
takemasa@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Pulmonary Medicine and
Clinical Immunology, Dokkyo Medical
University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Dokkyo Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Boston Scietific Japan Co. Ltd
Name of secondary funder(s)
Boston Scietific Japan Co. Ltd
IRB Contact (For public release)
Organization
Dokkyo Medical University School of Medicine
Address
880 Kitakobayashi, Mibu, Tochigi, Japan
Tel
0282-86-1111
m-syouji@dokkyomed.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
獨協医科大学（栃木県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 07 | Month | 29 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000032501
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
226
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Re-analysis is currently underway and will be published after the paper is submitted.
Date of the first journal publication of results
| 2023 | Year | 12 | Month | 30 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2017 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 28 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 12 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 12 | Month | 30 | Day |
Date analysis concluded
| 2020 | Year | 12 | Month | 30 | Day |
Other
Other related information
Retrospective and prospective study
Management information
Registered date
| 2017 | Year | 07 | Month | 26 | Day |
Last modified on
| 2023 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032501
