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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000028391
Receipt No. R000032501
Scientific Title Effectiveness and safety of bronchial thermoplasty multicenter study in Japan
Date of disclosure of the study information 2017/07/29
Last modified on 2017/07/26

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Basic information
Public title Effectiveness and safety of bronchial
thermoplasty multicenter study in Japan
Acronym Bronchial thermoplasty multicenter study
in Japan
Scientific Title Effectiveness and safety of bronchial
thermoplasty multicenter study in Japan
Scientific Title:Acronym Bronchial thermoplasty multicenter study
in Japan
Region
Japan

Condition
Condition Severe asthma
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness and safety ofbronchial thermoplasty for severe asthma
in Japanese multicenter study.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes QOL (quality of life)
Key secondary outcomes 1.Asthma exacerbation
2.Emergency room visits
3.Unscheduled physician office visits
4.Hospitalization frequency
5.Hospitalizations
6.Days missed from work/school
7.Physician's Global Evaluation of
Treatment Effectiveness (GETE)
assessment
8.Therapeutic drug use
9.Pulmonary function
10.Adverse events

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 1. Uncontrolled severe asthma patients
treated with high dose inhaled
corticosteroid and long-acting
beta2-agonists
2. Eligible for fiberoptic bronchoscopy
Key exclusion criteria 1. Have a pacemaker, implantable
cardioverter defibrillator, or other
implantable electronic device.
2. Have a known sensitivity to
medications required to perform
bronchoscopy, including lidocaine,
atropine, and benzodiazepines.
3. Have been previously treated with BT
4. Active respiratory infection
5. Asthma exacerbation or changing doseof systemic corticosteroids for asthma
in the past 14 days
6. Known coagulopathy. As with other
bronchoscopic procedures, patients should stop taking anticoagulants,
antiplatelet agents, aspirin, and
NSAIDS before the procedure with
physician guidance
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Akihiro Takemasa
Organization Dokkyo Medical University School of
Medicine
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Email takemasa@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Akihiro Takemasa
Organization Dokkyo Medical University School of Medicine
Division name Department of Pulmonary Medicine and Clinical Immunology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takemasa@dokkyomed.ac.jp

Sponsor
Institute Department of Pulmonary Medicine and
Clinical Immunology, Dokkyo Medical
University School of Medicine
Institute
Department

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
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 獨協医科大学(栃木県) 

Other administrative information
Date of disclosure of the study information
2017 Year 07 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 Preinitiation
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective and prospective study

Management information
Registered date
2017 Year 07 Month 26 Day
Last modified on
2017 Year 07 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032501

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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