UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Protective Effects of Bisoprolol against Acute Exacerbation in Moderate-to-Severe Chronic Obstructive Pulmonary Disease
Title of the study (Brief title)	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	Katsuyuki Kiura
Organization	Okayama University Hospital
Division name	Department of Allergy and Respiratory Medicine
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-7227
Email	kkiura@md.okayama-u.ac.jp

Public contact
Name of contact person	Akihiko Taniguchi
Organization	Okayama University
Division name	Health Service Center
Address	2-1-1 Tsushima-naka, Kita-ku, Okayama
TEL	086-251-7223
Homepage URL
Email	p0c17ter@okayama-u.ac.jp

Sponsor
Institute	Okayama University
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 12 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028404