UMIN-CTR Clinical Trial

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

chronic obstructive pulmonary disease, hypertension

Classification by specialty

Cardiology

Pneumology

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

The rate of acute exacerbation (moderate or more)

Key secondary outcomes

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

Email

kkiura@md.okayama-u.ac.jp

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

Email

p0c17ter@okayama-u.ac.jp

Institute

Okayama University

Institute

Department

Personal name

Organization

self-procurement

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

27

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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