UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003792 |
|---|---|
| Receipt number | R000004547 |
| Scientific Title | Evaluation of the effect of bronchodilator on COPD patients by physiological cost index |
| Date of disclosure of the study information | 2010/06/25 |
| Last modified on | 2010/06/21 11:31:47 |
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Basic information
Public title
Evaluation of the effect of bronchodilator on COPD patients by physiological cost index
Acronym
Effect of bronchodilator on COPD patients.
Scientific Title
Evaluation of the effect of bronchodilator on COPD patients by physiological cost index
Scientific Title:Acronym
Effect of bronchodilator on COPD patients.
Region
| Japan |
Condition
Condition
COPD
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We evaluate the effect of bronchodilator on exercise tolerance improvement of COPD patients by physiological cost index (PCI). PCI is calculated by pulse rate and walking speed during 6-minute walk test. PCI evaluates the exercise tolerance than the walking distance in 6-minute walk test.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
physiological cost index
Key secondary outcomes
Six-minite walk test
Lung function
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients inhale bronchodilator 15 minutes before 6-minute walk test.
Interventions/Control_2
Patients do not inhale bronchodilator before 6-minute walk test.
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
| 45 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD patients who can get outpatient treatment at Gunma University Hospital.
Key exclusion criteria
1. The patients who used inhaled bronchodilator within 24 hours.
2. The patients who have arrhythmia like atrial fibrillation.
3. The patients who have a history of ischemic heart disease.
4. The patients who have cardiac failure.
5. The patients who cannot do 6-minute walk test.
6. The patients whom a doctor decided inappropriate to join the study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunio Dobashi |
Organization
Gunma University
Division name
Faculty of Medicine, School of Health Sciences
Zip code
Address
3-39-15 Showa-machi, Maebashi, Gunma
TEL
027-220-8944
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kunio Dobashi |
Organization
Gunma University
Division name
Faculty of Medicine, School of Health Sciences
Zip code
Address
TEL
027-220-8944
Homepage URL
dobashi@health.gunma-u.ac.jp
Sponsor or person
Institute
Gunma University, Faculty of Medicine, School of Health Sciences
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
| 2010 | Year | 06 | Month | 25 | 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
| 2010 | Year | 04 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | 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
| 2010 | Year | 06 | Month | 21 | Day |
Last modified on
| 2010 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004547
