UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012795 |
|---|---|
| Receipt number | 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 20:57:50 |
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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
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
ykodama@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Faculty of Medicine and graduate
School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014944
| 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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