UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009577 |
|---|---|
| Receipt number | R000011188 |
| Scientific Title | Improvement of exercise tolerance by a long-term assisting use of the short acting beta 2 agonist (procaterol) for pulmonary rehabilitation in patients with COPD. |
| Date of disclosure of the study information | 2013/01/02 |
| Last modified on | 2012/12/13 13:59:30 |
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Basic information
Public title
Improvement of exercise tolerance by a long-term assisting use of the short acting beta 2 agonist (procaterol) for pulmonary rehabilitation in patients with COPD.
Acronym
Assisting use of procaterol for pulmonary rehabilitation in patients with COPD.
Scientific Title
Improvement of exercise tolerance by a long-term assisting use of the short acting beta 2 agonist (procaterol) for pulmonary rehabilitation in patients with COPD.
Scientific Title:Acronym
Assisting use of procaterol for pulmonary rehabilitation in patients with COPD.
Region
| Japan |
Condition
Condition
Chronic Obstructive Pulmonary Disease ; COPD
Classification by specialty
| Pneumology | Rehabilitation medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of inhaled short acting beta 2 agonist (procaterol) on breathlessness on exertion and effort of Activities of Daily Living (ADL) with COPD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Endurance shuttle walking test ;ESWT
Key secondary outcomes
Pulmonary Function Test
Borg CR-10(Category-Ratio 10)
SpO2, HR
Nagasaki University Respiratory ADL
Questionnaire
St. George's Respiratory Questionnaire
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Single inhalation of procaterol hydrochloride 20 microgram and pulmonary rehabilitation
Interventions/Control_2
Pulmonary rehabilitation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The COPD patients above the severity of moderate (GOLD 2) in stable phase, who recruited from in-outpatients and still have dyspnea on exertion despite therapy with long-acting bronchodilators.
Key exclusion criteria
The patients who considered to have risks for exercise test, such as coronary vascular disease, arrhythmia, and heart failure are excluded from this study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hajime Kurosawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-7874
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hajime Kurosawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Department of Occupational Health
Zip code
Address
2-1, Seiryo-machi, Aoba-ku, Sendai 980-8575, Japan
TEL
022-717-7874
Homepage URL
Sponsor or person
Institute
Department of Occupational Health, Tohoku University School of Medicine,
Institute
Department
Personal name
Funding Source
Organization
Tohoku University Graduate School of Medicine,
Nagasaki University Graduate School of Biomedical Science,
Juntendo University, Urayasu
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
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
東北大学病院（宮城県）
Tohoku University Hospital(Miyagi prefecture)
江東病院（東京都）
Koto Hospital (Tokyo)
長崎大学病院（長崎県）
Nagasaki University Hospital(Nagasaki prefecture)
長崎呼吸器リハビリクリニック（長崎県）
Nagasaki Pulmonary Rihabiritation Clinic(Nagasaki prefecture)
霧が丘つだ病院（福岡県）
Kirigaoka Tsuda Hospital (Fukuoka prefecture)
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 01 | Month | 02 | 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
Preinitiation
Date of protocol fixation
| 2012 | Year | 10 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 04 | 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 | 12 | Month | 18 | Day |
Last modified on
| 2012 | Year | 12 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011188
