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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000026060
Receipt No. R000029944
Scientific Title Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Date of disclosure of the study information 2017/02/10
Last modified on 2017/03/16

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Basic information
Public title Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Acronym PRE-THERMO
Scientific Title Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Scientific Title:Acronym PRE-THERMO
Region
Japan

Condition
Condition bronchial asthma
Classification by specialty
Pneumology Clinical immunology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find predictive factors for the effectiveness of the bronchial thermoplasty in patients with asthma.
Basic objectives2 Others
Basic objectives -Others To find predictive factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Discovery of the predictive factors for the effectiveness at 3 months after the final session of bronchial thermoplasty against bronchial asthma
Key secondary outcomes

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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Diagnosed as having asthma according to "Global Strategy for Asthma Management and Prevention (2016 update)".
2. Having asthma symptoms in the past year while receiving three or more controller medication including medium dose of inhaled corticosteroid or two or more controller medication including high dose of inhaled corticosteroid.
3. Receiving three or more controller medication including medium dose of inhaled corticosteroid or two or more controller medication including high dose of inhaled corticosteroid for more than 30 days.
4. Having asthma symptoms in the past while receiving high dose of inhaled corticosteroid and long-acting beta2-agonist.
Key exclusion criteria 1. Implantation of electoric device, such as a pacemaker.
2. Unable to receive medication which is used in the bronchoscopic procedure or in treatment of asthma exacerbation, such as lidocane, and systemic corticosteroid.
3. Previous history of bronchial thermoplasty or broncho-pulmonary surgery.
4. Severe complication such as respiratory infection, coagulation disorder, lung cancer, unstable ischemic heart disease and unstable cerebrovascular disease.
5. Unable to receive pulmonary function tests.
6. Intolerant of bronchoscopic procedure.
7. Women expecting a child or scheduled to be pregnant in 6 months.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kengo Murata
Organization Tokyo Metropolitan Tama Medical Center
Division name Pulmonology
Zip code
Address 2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL +81-42-323-5111
Email kengo_murata@tmhp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kengo Murata
Organization Tokyo Metropolitan Tama Medical Center
Division name Pulmonology
Zip code
Address 2-8-29, Musashidai, Fuchu-shi, Tokyo, Japan
TEL +81-42-323-5111
Homepage URL
Email kengo_murata@tmhp.jp

Sponsor
Institute Tokyo Metropolitan Tama Medical Center
Institute
Department

Funding Source
Organization Tokyo metropolitan goverment
Organization
Division
Category of Funding Organization Local Government
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
2017 Year 02 Month 10 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
2017 Year 02 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 02 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Design: Prospective study.
Recruitment;
Patients with asthma will be publicly recruited and be assessed for the eligibility at the outpatient clinic in Tama medical center.

Management information
Registered date
2017 Year 02 Month 08 Day
Last modified on
2017 Year 03 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029944

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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