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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035416
Receipt No. 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

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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
Email 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
Email shinjit-tky@umin.ac.jp

Sponsor
Institute Tokyo Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040351

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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