UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011848
Receipt number R000013849
Scientific Title Study on bronchus expansion effect on COPD patient of glycopyrronium bromide
Date of disclosure of the study information 2013/09/24
Last modified on 2018/09/28 14:41:51

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Basic information

Public title

Study on bronchus expansion effect on COPD patient of glycopyrronium bromide

Acronym

Study on bronchus expansion effect on COPD patient

Scientific Title

Study on bronchus expansion effect on COPD patient of glycopyrronium bromide

Scientific Title:Acronym

Study on bronchus expansion effect on COPD patient

Region

Japan


Condition

Condition

COPD

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this research is to evaluate the effect of a glycopyrronium bromide by many parameters of a respiratory function test, a COPD assessment test, and a breast image view (HRCT, lung vision, AZE) in the patient of a COPD.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

The rate of change of medical treatment start before of 3rd the 6th airway area (mm2) in three-dimensional respiratory tract analysis software, and two weeks after

Key secondary outcomes

The amount of change of 3rd the 6th airway area in three-dimensional respiratory tract analysis software
The difference of the amount of change of a COPD assessment test


Base

Study type


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Inhalation of a glycopyrronium bromide

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

40 years-old <=

Age-upper limit


 Not applicable

Gender

Male and Female

Key inclusion criteria

The adult aged 40 and over with this smoking history by which center visitor going to hospital regularly is carried out.
The patient who corresponds to a COPD
1 term and 2 term in a respiratory function test

Key exclusion criteria

The patient whom the examination responsibility (assignment) doctor judged to be unsuitable as a subject is excluded.
Lung tumor or the case in which a metastatic pulmonary tumor was accepted is excepted.

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name satoru ishii

Organization

national center for global health and medicine

Division name

respiratory department

Zip code


Address

1-21-1 Toyama Shinjuku-ku Tokyo

TEL

03-3202-7181

Email

satishii@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name satoru ishii

Organization

national center for global health and medicine

Division name

respiratory department

Zip code


Address

1-21-1 Toyama Shinjuku-ku Tokyo

TEL

03-3202-7181

Homepage URL


Email

satishii@hosp.ncgm.go.jp


Sponsor or person

Institute

national center for global health and medicine respiratory department

Institute

Department

Personal name



Funding Source

Organization

None

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


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

2013 Year 09 Month 24 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

Completed

Date of protocol fixation

2013 Year 03 Month 13 Day

Date of IRB


Anticipated trial start date

2013 Year 03 Month 14 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 24 Day

Last modified on

2018 Year 09 Month 28 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013849


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name