UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016046 |
|---|---|
| Receipt number | R000018651 |
| Scientific Title | The therapeutic efficacy of long acting beta2 stimulant in patients with early stage COPD |
| Date of disclosure of the study information | 2015/01/01 |
| Last modified on | 2014/12/24 15:34:07 |
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Basic information
Public title
The therapeutic efficacy of long acting beta2 stimulant in patients with early stage COPD
Acronym
The efficacy of LABA in early stage COPD
Scientific Title
The therapeutic efficacy of long acting beta2 stimulant in patients with early stage COPD
Scientific Title:Acronym
The efficacy of LABA in early stage COPD
Region
| Japan |
Condition
Condition
Patients with early stage COPD screened by medical examination
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of long acting beta2 stimulant (LABA) in patients with early stage COPD
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Amount of change in FEV1 between pre- and post-treatment
Key secondary outcomes
modified MRC socre, COPD assessment test (CAT), adverse events
Base
Study type
Interventional
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
4-week treatment with tiotropium followed by 4-week treatment with indacaterol
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)definite diagnosis of COPD
2)given informed consent
Key exclusion criteria
1)patients who are difficlut to perform frequent spirometry
2)patients with glaucoma
3)patients with urinary disturbance due to benign prostate hypertrophy
4)patients who are judged to be unfit to the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiko Nishioka |
Organization
Tokushima University Hospital
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima
TEL
+81-88-633-7127
yasuhiko@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Hanibuchi |
Organization
Tokushima University Hospital
Division name
Department of Respiratory Medicine and Rheumatology
Zip code
Address
2-50-1, Kuramoto-cho, Tokushima
TEL
+81-88-633-7127
Homepage URL
mhoney@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
徳島大学病院
Tokushima University Hospital
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 01 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2015 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2017 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2017 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 12 | Month | 24 | Day |
Last modified on
| 2014 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018651
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
