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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009657
Receipt No. 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

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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
Email

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
Email hayashs@cc.saga-u.ac.jp

Sponsor
Institute NPO Hagakure Respiratory Care Net
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011334

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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