Unique ID issued by UMIN | UMIN000007148 |
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Receipt number | R000008417 |
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 | 2012/02/01 |
Last modified on | 2012/01/26 17:40:17 |
Evaluation of clinical efficacy of
transdermal Tulobuterol to the small
airway dysfunction in patient with COPD.
Evaluation of IOS of transdermal
Tulobuterol.
Evaluation of clinical efficacy of
transdermal Tulobuterol to the small
airway dysfunction in patient with COPD.
Evaluation of IOS of transdermal
Tulobuterol.
Japan |
COPD(Chronic Obstructive Pulmonary
Disease)
Pneumology |
Others
NO
Evaluation of clinical efficacy of
transdermal Tulobuterol to the small
airway dysfunction.
Safety,Efficacy
Confirmatory
Pragmatic
Not applicable
Most Graph
Lung volumes
Evaluation of QOL
Respiratory function test
Dyspnea
Clinical symptom
Safe evaluation
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Transdermal Tulobuterol (0.5mg,1mg, 2mg)
40 | years-old | <= |
Not applicable |
Male and Female
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.
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.
10
1st name | |
Middle name | |
Last name | Keishi Kubo |
Shinshu University Hospital
1st Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Nagano
0263-37-2631
1st name | |
Middle name | |
Last name | Keishi Kubo |
Shinshu University Hospital
1st Department of Internal Medicine
3-1-1 Asahi, Matsumoto, Nagano
0263-37-2631
Kanazawa Medical University
None
Self funding
NO
2012 | Year | 02 | Month | 01 | Day |
Unpublished
Open public recruiting
2011 | Year | 11 | Month | 07 | Day |
2011 | Year | 12 | Month | 01 | Day |
2012 | Year | 01 | Month | 26 | Day |
2012 | Year | 01 | Month | 26 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008417
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