UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Predictive factor for the effectiveness of bronchial thermoplasty in patients with asthma
Title of the study (Brief title)	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	Kengo Murata
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Pulmonology
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	Kengo Murata
Organization	Tokyo Metropolitan Tama Medical Center
Division name	Pulmonology
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)

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

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 02 Month 10 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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