UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study on bronchus expansion effect on COPD patient of glycopyrronium bromide
Title of the study (Brief title)	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	satoru ishii
Organization	national center for global health and medicine
Division name	respiratory department
Address	1-21-1 Toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Email	satishii@hosp.ncgm.go.jp

Public contact
Name of contact person	satoru ishii
Organization	national center for global health and medicine
Division name	respiratory department
Address	1-21-1 Toyama Shinjuku-ku Tokyo
TEL	03-3202-7181
Homepage URL
Email	satishii@hosp.ncgm.go.jp

Sponsor
Institute	national center for global health and medicine respiratory department
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013849