UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009951 |
|---|---|
| Receipt number | R000011651 |
| Scientific Title | Comparison of indacaterol with tiotropium for stable COPD |
| Date of disclosure of the study information | 2013/02/04 |
| Last modified on | 2013/02/04 13:40:34 |
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Basic information
Public title
Comparison of indacaterol with tiotropium for stable COPD
Acronym
Comparison of indacaterol with tiotropium for stable COPD
Scientific Title
Comparison of indacaterol with tiotropium for stable COPD
Scientific Title:Acronym
Comparison of indacaterol with tiotropium for stable COPD
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effectiveness of indacaterol and tiotropium on COPD
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Forced oscillation method
Key secondary outcomes
pulmonary function test
modified Medical Research Council
COPD assessment test
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
indacaterol
Interventions/Control_2
tiotropium
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) patients with COPD
(2) age older than 20 year-old
(3) attending outpaient clinics
(4) obtaining informed consent
Key exclusion criteria
inappropriate patients
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshihiro Shirai |
Organization
Shizuoka General Hospital
Division name
Respiratory Medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka
TEL
054-247-6111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshihiro Shirai |
Organization
Shizuoka General Hospital
Division name
Respiratory Medicine
Zip code
Address
4-27-1 Kita-Ando, Aoi, Shizuoka
TEL
054-247-6111
Homepage URL
http://www.shizuoka-pho.jp/sogo/
tmjkshi@general-hosp.pref.shizuoka.jp
Sponsor or person
Institute
Shizuoka General Hospital
Institute
Department
Personal name
Funding Source
Organization
Shizuoka General Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
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 | 02 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2013 | Year | 02 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 04 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 02 | Month | 04 | Day |
Last modified on
| 2013 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011651
