UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020443 |
|---|---|
| Receipt number | R000023618 |
| Scientific Title | Biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma |
| Date of disclosure of the study information | 2016/01/06 |
| Last modified on | 2021/01/07 14:39:00 |
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Basic information
Public title
Biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma
Acronym
Biomarkers for bronchial thermoplasty
Scientific Title
Biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma
Scientific Title:Acronym
Biomarkers for bronchial thermoplasty
Region
| Japan |
Condition
Condition
Bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Discovery of biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Biomarker discovery for clinical efficacy of bronchial thermoplasty
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
-Unstable asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid and long acting beta2 agonist
-Willingness and ability to give written Informed Consent
-Willingness and ability to comply with the study protocol, including requirements for taking and abstaining from medications
Key exclusion criteria
-Use of an internal or external pacemaker or internal cardiac defibrillator
-Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
-lower respiratory tract infection
-Unstable asthma with an increased does of systemic corticosteroid within 2 weeks
-Bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 125,000/mm2 or known coagulopathy (INR > 1.5)
-Any active disease left untreated
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5802-1063
nor@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Norihiro |
| Middle name | |
| Last name | Harada |
Organization
Juntendo University school of medicine
Division name
Department of respiratory medicine
Zip code
113-8431
Address
3-1-3 Hongo, Bunkyo-ku, Tokyo, JAPAN
TEL
03-5802-1063
Homepage URL
nor@juntendo.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine, Juntendo University Faculty of Medicine and Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Juntendo University Research Ethics Committee
Address
2-1-1 Hongo, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-3111
kenkyu5858@juntendo.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
順天堂大学医学部附属順天堂医院呼吸器内科
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 06 | 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
13
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
Completed
Date of protocol fixation
| 2015 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 23 | Day |
Anticipated trial start date
| 2016 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The method of recruitment;
Subjects having any of the inclusion criteria will be recruited from our outpatient clinic at Juntendo University Hospital and Iizuka Hospital by March 31, 2020.
Management information
Registered date
| 2016 | Year | 01 | Month | 05 | Day |
Last modified on
| 2021 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023618
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
