UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006256 |
|---|---|
| Receipt number | R000007404 |
| Scientific Title | Evaluation of clinical efficacy of transdermal Tulobuterol to the small airway dysfunction in patient with COPD. |
| Date of disclosure of the study information | 2011/08/31 |
| Last modified on | 2013/10/03 10:11:33 |
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Basic information
Public title
Evaluation of clinical efficacy of transdermal Tulobuterol to the small airway dysfunction in patient with COPD.
Acronym
Evaluation of IOS of transdermal Tulobuterol.
Scientific Title
Evaluation of clinical efficacy of transdermal Tulobuterol to the small airway dysfunction in patient with COPD.
Scientific Title:Acronym
Evaluation of IOS of transdermal Tulobuterol.
Region
| Japan |
Condition
Condition
COPD(Chronic Obstructive Pulmonary Disease)
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of clinical efficacy of transdermal Tulobuterol to the small airway dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Most Graph
Lung volumes
Key secondary outcomes
Evaluation of QOL
Respiratory function test
Dyspnea
Clinical symptom
Safe evaluation
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
Transdermal Tulobuterol (0.5mg, 1mg, 2mg)
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
1)Patient who was diagnosed as COPD.
FEV1/FVC level is within 70% after 15 minutes to one hour used the bate2 agonist on respiratory function test that it was performed eight weeks ago from two weeks, and FEV1 level is within 80% more than 30%.
2)Patient that there is sustained dyspnea, and a symptom maintains the same.
3)40 years old and more than it, sex no object.
4)Smoker or patient with the smoking history.
5)No object according to a thing of hospitalization / an outpatient, but do not change the state, during study.
Key exclusion criteria
1)Patient of the symptom that bronchial asthma is main.
2)Patient who takes oral corticosteroid.
3)Patient who uses home oxygen therapy.
4)Patients with a history of hypersensitivity to Tulobuterol.
5)Patient who was considered ineligible to use transdermal Tulobuterol in a patient having skin diseases such as atopic dermatitis.
6)Patient who was considered ineligible to use bata2 agonist in a patient complicated with hyperthyroidism, hypertension, heart disease and diabetes mellitus.
7)Woman who are pregnant or breast feeding, and woman of childbearing potential.
8)Patient who was considered ineligible by the investigators.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirohisa Toga |
Organization
Kanazawa Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
toga-h@kanazawa-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirohisa Toga |
Organization
Kanazawa Medical University Hospital
Division name
Respiratory Medicine
Zip code
Address
1-1 Daigaku, Uchinada, Kahoku, Ishikawa
TEL
076-286-2211
Homepage URL
toga-h@kanazawa-med.ac.jp
Sponsor or person
Institute
Kanazawa Medical University
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
| 2011 | Year | 08 | Month | 31 | 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
Completed
Date of protocol fixation
| 2011 | Year | 07 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 09 | 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
| 2011 | Year | 08 | Month | 31 | Day |
Last modified on
| 2013 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007404
| 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 |
