UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030832
Receipt number R000035193
Scientific Title Study of Mediators Before and After Bronchial Thermoplasty in Bronchial Asthma
Date of disclosure of the study information 2018/01/17
Last modified on 2020/01/21 15:41:39

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Basic information

Public title

Study of Mediators Before and After Bronchial Thermoplasty in Bronchial Asthma

Acronym

Study of Mediators by Bronchial Thermoplasty in Bronchial Asthma

Scientific Title

Study of Mediators Before and After Bronchial Thermoplasty in Bronchial Asthma

Scientific Title:Acronym

Study of Mediators by Bronchial Thermoplasty in Bronchial Asthma

Region

Japan


Condition

Condition

bronchial asthma

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Compare the effects of bronchial thermoplasty treatment(BT)on serum and urinary mediators, before and after BT, one month after BT, and one year later.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Compare the effects of bronchial thermoplasty treatment(BT)on serum and urinary mediators, before and after BT, one month after BT, and one year later.

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

Other

Interventions/Control_1

We compare the effects of bronchial thermoplasty treatment(BT)on serum mediators, before and after BT, one month after BT, and one year later.

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

75 years-old >

Gender

Male and Female

Key inclusion criteria

Patients who satisfied the criteria of bronchial asthma and were diagnosed as severe bronchial asthma under the Japanese Allergy Society's asthma management guidelines.

Key exclusion criteria

Patients whom attending physician advised not to entry.

Target sample size

40


Research contact person

Name of lead principal investigator

1st name Imaizumi
Middle name
Last name Kazuyoshi

Organization

Fujita Health University of Medicine

Division name

Department of Respiratory Medicine

Zip code

4701192

Address

Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan

TEL

81-562-93-2111

Email

jeanluc@fujita-hu.ac.jp


Public contact

Name of contact person

1st name Isogai
Middle name
Last name Sumito

Organization

Fujita Health University of Medicine

Division name

Department of Respiratory Medicine

Zip code

470-1192

Address

Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan

TEL

81-562-93-2111

Homepage URL

http://kokyuki-fujita.net/hm17-287/

Email

hirosimax2000@yahoo.co.jp


Sponsor or person

Institute

Department of Respiratory Medicine, Fujita Health University of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Respiratory Medicine, Fujita Health University of Medicine

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

Department of Respiratory Medicine, Fujita Health University of Medicine

Address

Dengakugakubo 1-98, Kutsukakecho,Toyoake, Aichi 470-1192, Japan

Tel

81-562-93-2111

Email

hirosimax2000@yahoo.co.jp


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 01 Month 17 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 11 Month 01 Day

Date of IRB

2017 Year 10 Month 09 Day

Anticipated trial start date

2018 Year 01 Month 04 Day

Last follow-up date

2022 Year 10 Month 08 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 01 Month 16 Day

Last modified on

2020 Year 01 Month 21 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035193


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name