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
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
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
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
