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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012795
Receipt No. R000014944
Scientific Title Effects of Tulobuterol Patch (Long acting beta-2 agonist) on dyspnea during exercise in patients with COPD
Date of disclosure of the study information 2014/01/08
Last modified on 2014/01/08

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Basic information
Public title Effects of Tulobuterol Patch (Long acting beta-2 agonist) on dyspnea during exercise in patients with COPD
Acronym Effects of Tulobuterol Patch in COPD
Scientific Title Effects of Tulobuterol Patch (Long acting beta-2 agonist) on dyspnea during exercise in patients with COPD
Scientific Title:Acronym Effects of Tulobuterol Patch in COPD
Region
Japan

Condition
Condition Chronic obstructive pulmonary
disease (COPD)
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Evaluation for efficiency of tulobuterol patch on dyspnea in COPD patients during exercise
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Improvement for dyspnea in COPD patients in diary living and exercise activities
Key secondary outcomes Improvement for pulmonary function value in COPD

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 Behavior,custom
Interventions/Control_1 Tulobuterol Patch
ADL, exercise tolerance
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 Subjects: COPD patients
COPD was diagnosed based on the patient medical history, spirometry, and radiologic findings, including high-resolution computed tomography of the chest according to Global Initiative for Chronic Obstructive Lung Disease(GOLD) guideline.
Inclusion criteria included the presence of moderate to severe COPD, including post-bronchodilator forced expiratory volume in 1s (FEV1)/forced vital capacity (FVC) ratio of <70% and percent predicted FEV1 (%FEV1) <80%. Only patients whose condition had remained stable for >= 1 month more were eligible.
Key exclusion criteria Patients with any of the following were excluded:
1)Bronchial asthma
2)Respiratory tract infection within the preceding 4 weeks
3)Respiratory failure with home oxygen therapy
4)who required oral corticosteroids
5)hypertension, heart disease, thyroid disease, diabetes, or skin disease
and patients contraindicated to beta-2 agonists
6)Pregnant
7)others contraindicated to exercise
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuzo Kodama
Organization Juntendo University Scool of Medicine
Division name Respiratory Medicine
Zip code
Address 2-1-1 Hongo Bunkyoku Tokyo Japan
TEL +81-3-5802-1063
Email ykodama@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuzo Kodama
Organization Juntendo University Scool of Medicine
Division name Respiratory Medicine
Zip code
Address 2-1-1 Hongo Bunkyoku Tokyo Japan
TEL +81-3-5802-1063
Homepage URL
Email ykodama@juntendo.ac.jp

Sponsor
Institute Juntendo University
Faculty of Medicine and graduate
School of Medicine
Institute
Department

Funding Source
Organization Abbott Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization Japan

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 順天堂大学医学部附属順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 08 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
Tulobuterol patch produces significant improvement in dyspnea during exercise in stable COPD and may contribute to improve the quality of life in patients with COPD.
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 03 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 Month 01 Day
Last follow-up date
2013 Year 03 Month 31 Day
Date of closure to data entry
2013 Year 03 Month 31 Day
Date trial data considered complete
2013 Year 03 Month 31 Day
Date analysis concluded
2013 Year 11 Month 01 Day

Other
Other related information Pulmonary function test (spirometric indices) were not improved.

Management information
Registered date
2014 Year 01 Month 08 Day
Last modified on
2014 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014944

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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