UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024712 |
|---|---|
| Receipt number | R000028404 |
| Scientific Title | Protective Effects of Bisoprolol against Acute Exacerbation in Moderate-to-Severe Chronic Obstructive Pulmonary Disease |
| Date of disclosure of the study information | 2016/12/27 |
| Last modified on | 2018/05/09 23:36:08 |
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Basic information
Public title
Protective Effects of Bisoprolol against Acute Exacerbation in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Acronym
Effects of Bisoprolol on Acute Exacerbation of COPD
Scientific Title
Protective Effects of Bisoprolol against Acute Exacerbation in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Scientific Title:Acronym
Effects of Bisoprolol on Acute Exacerbation of COPD
Region
| Japan |
Condition
Condition
chronic obstructive pulmonary disease, hypertension
Classification by specialty
| Cardiology | Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of bisoprolol on acute exacerbation of chronic obstructive pulmonary disease
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The rate of acute exacerbation (moderate or more)
Key secondary outcomes
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 |
Interventions/Control_1
administration of bisoprolol, increased from 1.25mg/day to 2.5mg at a month intervals up to 5mg if tolerated.
It will be continued after the end of this study unless the patient want to discontinue or this study reveal the disadvantage of the medication.
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
(1) patients with chronic obstructive pulmonary disease
(2) a postbronchodilator FEV1(forced expiratory volume) of 70% or less of the FVC(forced vital capacity)
(3) a postbronchodilator FEV1 of 80% or less of the predicted value
(4) an age of 40 years or more
(5) 10 pack-years smoking history
(6) hypertension
(7) adequate organ function
Key exclusion criteria
(1) patients with severe (NYHA grade 3 or 4) cardiac failure
(2) left ventricular contractility of 40% or less
(3) 2nd/3rd-degree atrioventricular block, sinoatrial block or sick sinus syndrome
(4) variant angina pectoris
(5) severe peripheral circulatory disturbance
(6) pulmonary hypertension from right cardiac failure
(7) a history of pulmonary resection
(8) malignancy of disease-free interval of less than 3 years
(9) systolic blood pressure of less than 100 mmHg
(10) cardiac rate of less than 60 bpm on a constant basis
(11) uncontrolled diabetic mellitus
(12) thyrotoxicosis
(13) pheochromocytoma
(14) psoriasis
(15) use of supplemental oxygen or with SpO2 of less than 90%(or PaO2 of less than 60 Torr)
(16) asthma
(17) active interstitial pneumonia
(18) COPD exacerbation or respiratory infection within 4 weeks before registration
(19) pregnant women
(20) current use of beta-blocker
(21) history of hypersensitivity to bisoprolol
(22) patients considered to be inappropriate for this study by attending physician
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuyuki Kiura |
Organization
Okayama University Hospital
Division name
Department of Allergy and Respiratory Medicine
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama
TEL
086-235-7227
kkiura@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Akihiko Taniguchi |
Organization
Okayama University
Division name
Health Service Center
Zip code
Address
2-1-1 Tsushima-naka, Kita-ku, Okayama
TEL
086-251-7223
Homepage URL
p0c17ter@okayama-u.ac.jp
Sponsor or person
Institute
Okayama University
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 12 | Month | 27 | 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
| 2016 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | Month | 27 | 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
| 2016 | Year | 11 | Month | 04 | Day |
Last modified on
| 2018 | Year | 05 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028404
