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
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
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
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
