UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026060
Receipt number 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 18:25:52

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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 or person

Institute

Tokyo Metropolitan Tama Medical Center

Institute

Department

Personal name



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

Value
https://center6.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