UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031982 |
|---|---|
| Receipt number | R000036509 |
| Scientific Title | The effect of bronchial thermoplasty on severe asthmatic cough. |
| Date of disclosure of the study information | 2018/05/01 |
| Last modified on | 2022/04/04 21:51:09 |
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Basic information
Public title
The effect of bronchial thermoplasty on severe asthmatic cough.
Acronym
The effect of BT on severe asthmatic cough
Scientific Title
The effect of bronchial thermoplasty on severe asthmatic cough.
Scientific Title:Acronym
The effect of BT on severe asthmatic cough
Region
| Japan |
Condition
Condition
Severe classical asthma, severe cough-predominant asthma, and severe cough-variant asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of bronchial thermoplasty on severe asthmatic cough.
Basic objectives2
Others
Basic objectives -Others
To investigate the mechanisms of bronchial thermoplasty on severe asthmatic cough.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The improvement of cough intensity and cough specific quality of life.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Bronchial thermoplasty will be performed at 3-week intervals.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Severe classical asthma, severe cough-predominant asthma, and severe cough-variant asthma whose asthma or cough control are poor irrespective of high dose inhaled corticosteroids (ICS).
Key exclusion criteria
Those who meet the contraindication criteria of bronchial thermoplasty.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology Graduate School of Medical Sciences
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528538216
kaney32@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Yoshihiro |
| Middle name | |
| Last name | Kanemitsu |
Organization
Nagoya City University
Division name
Dept of Respiratory Medicine, Allergy and Clinical Immunology Graduate School of Medical Sciences
Zip code
4678601
Address
1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Aichi, Japan
TEL
0528538216
Homepage URL
kaney32@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Naogya City University
Institute
Department
Personal name
Funding Source
Organization
Self-sustaining
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
Department of Respiratory Medicine, Allergy and Clinical Immunology, Nagoya City University Graduate School of Medical Sciences,
Address
1 Kawasumi, Mizuho-Cho, Mizuho-Ku
Tel
0528538216
kaney32@med.nagoya-cu.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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 03 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 03 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2022 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036509
