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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008123
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of respiratory medicine, Graduate school of medicine, Osaka City University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007742

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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