UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024602 |
|---|---|
| Receipt number | R000028291 |
| Scientific Title | Exploratory research for unknown mechanism of bronichial thermoplasty in difficult asthma. |
| Date of disclosure of the study information | 2016/10/29 |
| Last modified on | 2017/06/16 12:13:24 |
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Basic information
Public title
Exploratory research for unknown mechanism of bronichial thermoplasty in difficult asthma.
Acronym
Exploratory research for a mechanism of bronichial thermoplasty.
Scientific Title
Exploratory research for unknown mechanism of bronichial thermoplasty in difficult asthma.
Scientific Title:Acronym
Exploratory research for a mechanism of bronichial thermoplasty.
Region
| Japan |
Condition
Condition
Difficult Asthma
Classification by specialty
| Pneumology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the target molecule related to the regulatory signal of BT in airway remodeling and explore the unknown mechanism of BT in defficult asthma.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detection of target molecules on BT
Key secondary outcomes
Effect of BT, Safety of BT, quality of life, physical activity
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
Patients will be eligible for inclusion in this study if all of the following criteria are met:
1.Patients with symptoms such as paroxysmal wheezing, cough, dyspnoea, etc., who are diagnosed with asthma based on a significant airway reversibility and / or airway hyperresponsiveness
2.Patients with step3 or 4 in asthma treatment by JGL
3.Patients are stable for at least 2 weeks prior to this study and can safely receive fiberoptic bronchoscopy.
4.Patients whose age is over 20 on informed consent acquisition date
5.Male and Female
6.Patients received an explanation of the study protocol and gave written informed consent.
7.Subjects are regardless of inpatients or outpatients.
Key exclusion criteria
Patients will be excluded in this study if any of the following criteria exist:
1.Patients have had an exacerbation for 2 weeks prior to this study and have been changed therapeutic strategy in stable status.
2.Patients judged as poor adherence to therapy.(ASK20 is used to assess it)
3.Patients are inadequate to include in this study.(EX: complication of malignant tumor).
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tsunahiko Hirano |
Organization
Yamaguchi University Hospital
Division name
Respiratory Medicine and Infectious Disease
Zip code
Address
1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL
0836-85-3123
tsuna@yamaguchi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tsunahiko Hirano |
Organization
Yamaguchi University Hospital
Division name
Respiratory Medicine and Infectious Disease
Zip code
Address
1-1-1 Minami-kogushi, Ube, 755-8505, Japan
TEL
0836-85-3123
Homepage URL
tsuna@yamaguchi-u.ac.jp
Sponsor or person
Institute
Yamaguchi University Hospital
Respiratory Medicine and Infectious Disease
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
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
山口大学医学部附属病院（山口県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 29 | 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 | 07 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 31 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Case-referent study
Recruit subjects by posters
Management information
Registered date
| 2016 | Year | 10 | Month | 28 | Day |
Last modified on
| 2017 | Year | 06 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028291
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
