UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031202 |
|---|---|
| Receipt number | R000035627 |
| Scientific Title | Evaluation of Biomarkers among Patients Undergoing Bronchial Thermoplasty |
| Date of disclosure of the study information | 2018/02/08 |
| Last modified on | 2022/06/01 16:10:07 |
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Basic information
Public title
Evaluation of Biomarkers among Patients
Undergoing Bronchial Thermoplasty
Acronym
Evaluation of Biomarkers among Patients
Undergoing Bronchial Thermoplasty
Scientific Title
Evaluation of Biomarkers among Patients
Undergoing Bronchial Thermoplasty
Scientific Title:Acronym
Evaluation of Biomarkers among Patients
Undergoing Bronchial Thermoplasty
Region
| Japan |
Condition
Condition
severe asthma
Classification by specialty
| Pneumology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
elucidate the mechanisms of action of BT treatment
Basic objectives2
Others
Basic objectives -Others
elucidate the mechanisms of action of BT treatment
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the relationships between the fluctuation of the biomarker(s) and response to BT defined by improvement in asthma quality of life
Key secondary outcomes
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
Diagnosis of severe asthma based on the criteria of the American Thoracic Society
Age above 18 years
Plan to undergo BT
Ability to provide informed consent
Key exclusion criteria
asthma exacerbation during the prior month
oral corticosteroid use greater than 30 mg/day
use of immunosuppressants
respiratory diseases such as emphysema
use of beta-adrenergic blocking agents
use of anticoagulants
previous BT treatment
any issue which in the opinion of the investigator might interfere with participation in this study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Ken |
| Middle name | |
| Last name | Ohta |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
240-8585
Address
3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL
042-491-2111
kenohta@tokyo-hosp.jp
Public contact
Name of contact person
| 1st name | Maho |
| Middle name | |
| Last name | Suzukawa |
Organization
National Hospital Organization Tokyo National Hospital
Division name
Clinical Research Center
Zip code
240-8585
Address
3-1-1 Takeoka, Kiyose, Tokyo 204-8585
TEL
042-491-2111
Homepage URL
fueta-tky@umin.ac.jp
Sponsor or person
Institute
National Hospital Organization
Tokyo National Hospital
Institute
Department
Personal name
Funding Source
Organization
Boston Scientific
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Tokyo National Hospital
Address
3-1-1 Takeoka, Kiyose-Shi, Tokyo, Japan
Tel
042-491-2111
goto.yumiko.zj@mail.hosp.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
| 2018 | Year | 02 | Month | 08 | 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
26
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
No longer recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 27 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 27 | Day |
Last follow-up date
| 2020 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A total of 20 patients undergoing BT will be recruited and prospectively followed for one year after the treatment period. Samples will be collected at each BT (at first BT, second BT at week 3 and third BT at week 6) before the procedure from the same bronchus (right B8), and biomarkers will be measured by either ELISA or multiplex bead assay. Clinical, physiologic and imaging assessment will be taken before each BT and one year after the treatment period. Airway hyperresponsiveness to methacholine (if possible) and patients' asthma control and questionnaires will be taken and patient medications as well as annualized asthma related adverse events will be collected before and one year after the treatment period.
Management information
Registered date
| 2018 | Year | 02 | Month | 08 | Day |
Last modified on
| 2022 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035627
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
