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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000007148
Receipt No. 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

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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
Last name of lead principal investigator
1st name
Middle name
Last name Keishi Kubo
Organization Shinshu University Hospital
Division name 1st Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2631
Email

Public contact
1st name of contact person
1st name
Middle name
Last name Keishi Kubo
Organization Shinshu University Hospital
Division name 1st Department of Internal Medicine
Zip code
Address 3-1-1 Asahi, Matsumoto, Nagano
TEL 0263-37-2631
Homepage URL
Email

Sponsor
Institute Kanazawa Medical University
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2012 Year 02 Month 01 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 Open public recruiting
Date of protocol fixation
2011 Year 11 Month 07 Day
Date of IRB
Anticipated trial start date
2011 Year 12 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 01 Month 26 Day
Last modified on
2012 Year 01 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008417

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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