UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008123 |
|---|---|
| Receipt number | R000007742 |
| Scientific Title | The effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation |
| Date of disclosure of the study information | 2012/06/07 |
| Last modified on | 2015/03/16 18:52:31 |
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Basic information
Public title
The effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation
Acronym
The effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation
Scientific Title
The effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation
Scientific Title:Acronym
The effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of tulobuterol patch on exercise tolerance in COPD patients with pulmonary rehabilitation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the length in 6 minutes walking test after pulmonry rehabilitation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Tulobuterolpatch
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
COPD GOLD Stage II - III
Need Pulmonary Rehabilitation
Over 40 years old
EX- or current smoker
Key exclusion criteria
Bronchial asthma
Allergic rhinitis
elevated eoshinophil in peripheral blood
Pulmonary infection within two month
orthopedic complication not suitable for exercise
Recent cardiac infarction or heart failure
Body weight loss(>4.5Kg in one year)
hypoxia under the LTOT
allergy to turobuterol
Pregnancy
Investigator's decision
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhisa Asai |
Organization
Graduate school of medicine, Osaka City University
Division name
Department of respiratory medicine
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Graduate school of medicine, Osaka City University
Division name
Department of respiratory medicine
Zip code
Address
1-4-3, Asahimachi, Abenoku, Osaka
TEL
Homepage URL
Sponsor or person
Institute
Department of respiratory medicine, Graduate school of medicine, Osaka City University
Institute
Department
Personal name
Funding Source
Organization
Department of respiratory medicine, Graduate school of medicine, Osaka City University
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
| 2012 | Year | 06 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2011 | Year | 10 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | 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
| 2012 | Year | 06 | Month | 07 | Day |
Last modified on
| 2015 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007742
| 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 |
