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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000009577
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Department of Occupational Health, Tohoku University School of Medicine,
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011188

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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