UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000026176
Receipt number R000030038
Scientific Title Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma
Date of disclosure of the study information 2017/02/20
Last modified on 2021/02/19 16:07:55

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Basic information

Public title

Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma

Acronym

Prospective observational study for exploring biomarkers of bronchial thermoplasty

Scientific Title

Prospective observational study for exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with bronchial asthma

Scientific Title:Acronym

Prospective observational study for exploring biomarkers of bronchial thermoplasty

Region

Japan


Condition

Condition

Bronchial asthma

Classification by specialty

Pneumology Clinical immunology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

Exploring biomarkers predictive for clinical efficacy of bronchial thermoplasty in patients with asthma

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

Exploring biomarkers of bronchial thermoplasty in bronchial asthma by the method of omics approach

Key secondary outcomes

Unexpected visits and admission for exacerbation of bronchial asthma
Change of bronchial asthma related quality of life, spirometry parameters and fractional exhaled nitric oxide


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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1) Previously treated over a year after diagnosis of bronchial asthma
2) Bronchial asthma requiring regular maintenance medication that includes high dose inhaled corticosteroid and long acting beta2 agonist,
Willingness and ability to bronchial thermoplasty
3) Permit the other medication in combination such as anti-leukotriene antagonists, xanthine derivatives, omalizumab and systemic corticosteroids within 10 mg/day, expectorants
4) Adequate organ functions
5) Life expectancy more than a year
6) Willingness and ability to give written informed consent

Key exclusion criteria

1) Implantation of an internal or external pacemaker or internal cardiac defibrillator
2) Known sensitivity to medications required to perform bronchoscopy, including lidocaine, atropine and benzodiazepines
3) lower respiratory tract infection
4) Unstable asthma with an increased does of systemic corticosteroids within 2 weeks
5) Known coagulopathy
6) As with other bronchoscopic procedures, patients should stop taking anticoagulants, antiplatelet agents, aspirin, and NSAIDs before the procedure with physician guidance
7) Any other condition, which in the opinion of the investigator would preclude participation in the study

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Hiroaki
Middle name
Last name Tsurumaki

Organization

Gunma University Hospital

Division name

Division of Allergy and Respiratory Medicine

Zip code

371-8511

Address

3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-8130

Email

m12702056@gunma-u.ac.jp


Public contact

Name of contact person

1st name Hiroaki
Middle name
Last name Tsurumaki

Organization

Gunma University Hospital

Division name

Division of Allergy and Respiratory Medicine

Zip code

3718511

Address

3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan

TEL

027-220-8130

Homepage URL


Email

m12702056@gunma-u.ac.jp


Sponsor or person

Institute

Gunma University

Institute

Department

Personal name



Funding Source

Organization

non

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

Gunma University Hospital Institutional Review Board

Address

3-39-15 Showa-machi, Maebashi, Gunma, 371-8511, Japan

Tel

027-220-8740

Email

gunmaciru-office@umin.ac.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

群馬大学医学部附属病院(群馬県)/Gunma University Hospital(Gunma)


Other administrative information

Date of disclosure of the study information

2017 Year 02 Month 20 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

3

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

Completed

Date of protocol fixation

2017 Year 02 Month 01 Day

Date of IRB

2017 Year 01 Month 26 Day

Anticipated trial start date

2017 Year 02 Month 01 Day

Last follow-up date

2021 Year 01 Month 31 Day

Date of closure to data entry

2021 Year 02 Month 19 Day

Date trial data considered complete

2021 Year 02 Month 19 Day

Date analysis concluded

2021 Year 02 Month 19 Day


Other

Other related information

Study design; Prospective observational study

Registration: February. 2016 to January. 2020, compatible with inclusion criteria.

Using blood sample and exhaled breath condensate, any biomarkers before and after bronchial thermoplasty are measured. We explore biomarkers predictive for clinical efficacy in a year after bronchial thermoplasty.


Management information

Registered date

2017 Year 02 Month 16 Day

Last modified on

2021 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030038


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name