UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009657 |
|---|---|
| Receipt number | R000011334 |
| Scientific Title | The effect of indacaterol on exercise tolelability |
| Date of disclosure of the study information | 2013/01/04 |
| Last modified on | 2012/12/28 13:25:54 |
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Basic information
Public title
The effect of indacaterol on exercise
tolelability
Acronym
indacaterol and exercise tolelability
Scientific Title
The effect of indacaterol on exercise
tolelability
Scientific Title:Acronym
indacaterol and exercise tolelability
Region
| Japan |
Condition
Condition
chronic obstructive lung disease
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine whether administration of
indacaterol suppresses dynamic hyper
inflation of lung and improve exercise
tolerability of COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The improvement of endurance shattle
walking test distance 30 days after the start of daily indacaterol.
Key secondary outcomes
1 The improvement of COPD assessment test score and dynamic hyperinflation 30 days after the start of daily indacaterol.
2. The improvement of FEV1 after indacaterol inhalation.
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
inhalation of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) COPD is stable
2) be able to give written informed consent
Key exclusion criteria
1) severe medical condition other than COPD.
2) arthral disease with pain which impairs walking.
3) a person who cannot uderstand the
purpose and the method of this clinical study
4) a person who was assessed inappropriate for this clinical study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichiro Hayashi |
Organization
Saga University Medical School Hospital
Division name
Respirology
Zip code
Address
5-1-1 Nabeshima Saga
TEL
0952-34-2356
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shinichiro Hayashi |
Organization
Saga University Medical School Hospital
Division name
Respirology
Zip code
Address
5-1-1 Nabeshima Saga
TEL
0952-34-2356
Homepage URL
hayashs@cc.saga-u.ac.jp
Sponsor or person
Institute
NPO Hagakure Respiratory Care Net
Institute
Department
Personal name
Funding Source
Organization
NPO Hagakure Respiratory Care Net
Organization
Division
Category of Funding Organization
Self funding
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
佐賀大学医学部附属病院(佐賀県）、佐賀県立病院好生館（佐賀県）、佐賀社会保険病院（佐
賀県）、社会保険浦之崎病院（佐賀県）、長生堂渡辺医院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | 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
| 2012 | Year | 12 | Month | 28 | Day |
Last modified on
| 2012 | Year | 12 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011334
