UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018140 |
|---|---|
| Receipt number | R000021000 |
| Scientific Title | Effectiveness and safety of bronchial thermoplasty in the treatment with severe persistent bronchial asthma |
| Date of disclosure of the study information | 2015/06/30 |
| Last modified on | 2023/07/06 20:24:32 |
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Basic information
Public title
Effectiveness and safety of bronchial thermoplasty in the treatment with severe persistent bronchial asthma
Acronym
Effectiveness and safety of bronchial thermoplasty in patients with severe asthma
Scientific Title
Effectiveness and safety of bronchial thermoplasty in the treatment with severe persistent bronchial asthma
Scientific Title:Acronym
Effectiveness and safety of bronchial thermoplasty in patients with severe asthma
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 the treatment of severe asthma in Japanese patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Asthma exacerbation
Key secondary outcomes
Asthma control
Pulmonary function
QOL
Bronchial wall thickness, diameter
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
| 20 | 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 beta 2 agonists
2.Eligible for fiberoptic bronchoscopy
Key exclusion criteria
1.Have a pacemaker, internal 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 (up or down) 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
30
Research contact person
Name of lead principal investigator
| 1st name | Motoyasu |
| Middle name | |
| Last name | Iikura |
Organization
National Center for Global Health and Medicine
Division name
Respiratory Medicine
Zip code
162-8655
Address
Toyama 1-21-1, Shinjukuku, Tokyo, Japan
TEL
03-3202-7181
iikura-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Motoyasu |
| Middle name | |
| Last name | Iikura |
Organization
National Center for Global Health and Medicine
Division name
Respiratory Medicine
Zip code
162-8655
Address
Toyama 1-21-1, Shinjukuku, Tokyo, Japan
TEL
03-3202-7181
Homepage URL
iikura-tky@umin.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, National Center for Global Health and Medicine
Institute
Department
Personal name
Funding Source
Organization
National Center for Global Health and Medicine
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
Certified Review Board of National Center for Global Health and Medicine
Address
Toyama 1-21-1, Shinjukuku, Tokyo, Japan
Tel
03-3202-7181
kenkyu-shinsa@hosp.ncgm.go.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
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S1323893017301077?via%3Dihub
Number of participants that the trial has enrolled
30
Results
Asthma-related Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ)-5 scores were improved at both 1 and 12 months after BT. Mean FEV1 was increased at 1 and 12 months. The mean annual number of severe exacerbations requiring systemic corticosteroids decreased from 5.8 to 2.0 at 12 months after BT. No serious adverse event was observed.
Results date posted
| 2023 | Year | 07 | Month | 06 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 07 | Month | 29 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Improvement of Asthma-related Quality of Life Questionnaire (AQLQ) and Asthma Control Questionnaire (ACQ)-5 scores, %FEV1 and reduction of severe asthma exacerbation were obsereved at 12 months after BT.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2015 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2024 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective study
Management information
Registered date
| 2015 | Year | 06 | Month | 30 | Day |
Last modified on
| 2023 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021000
| Research Plan | |
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| Registered date | File name |
| Research case data | |
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