UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035416 |
|---|---|
| Receipt number | R000040351 |
| Scientific Title | Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma |
| Date of disclosure of the study information | 2018/12/31 |
| Last modified on | 2018/12/31 07:50:21 |
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Basic information
Public title
Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Acronym
Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Scientific Title
Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Scientific Title:Acronym
Efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Region
| Japan |
Condition
Condition
bronchial asthma
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the efficacy, safety, and pulmonary functions of bronchial thermoplasty in patients with severe asthma
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Post BT treatment complications, therapeutic control level, pulmonary functions
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
bronchial thermoplasty
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1)Severe uncontrolled bronchial asthma on high-dose inhaled corticosteroids, which is equivalent to 1000 or more micro g/day of beclomethasone dipropionate and long-acting beta 2 agonist
2)Ability to tolerate bronchoscopy and suitable for bronchial thermoplasty
3)Aged 20 years old and older
4)Provided written informed consent to participate in the study
Key exclusion criteria
1)Malignant tumors
2)Severe heart disease
3)Severe hepatic failure
4)Severe renal failure (serum creatinine levels 2.0 or more mg/dl)
5)Current use of a body defibrillator, such as pacemaker or implantable cardioverter defibrillator
6)Active infectious disease
7)Exacerbation of asthma or change in the drug regimen to include oral corticosteroids in the past 14 days
8)Change in the maintenance drug therapy for bronchial asthma in the past 4 weeks
9)Less than 65% post-bronchodilator %FEV1
10)Uncontrolled sinusitis
11)Requirement for oral steroid that is equivalent to more than 10 mg/day of prednisone to control bronchial asthma
12)Past history of intubation or admission to the intensive care unit due to bronchial asthma in the past 24 months
13)Past history in the past 12 months as follows; i) 4 or more infections of the lower respiratory tract, or ii) 3 or more admissions due to respiratory symptoms
14)Has smoked in the past 12 months or has a smoking history of 10 or more pack-years
15)Has previously undergone bronchial thermoplasty
16)Pregnancy or potential pregnancy
17)Judged inadequate to participate in the study by their physicians
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshio Ichiwara |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
1163 Tatemachi Hajiojishi Tokyo
TEL
042-665-5611
ichiwata@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinji Teramoto |
Organization
Tokyo Medical University Hachioji Medical Center
Division name
Department of Respiratory Medicine
Zip code
Address
1163 Tatemachi Hajiojishi Tokyo
TEL
042-665-5611
Homepage URL
shinjit-tky@umin.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo mecical university
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
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 12 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 12 | Month | 31 | Day |
Last modified on
| 2018 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040351
