ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

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Trial registered on ANZCTR

Registration number

ACTRN12617001635358

Ethics application status

Approved

Date submitted

24/11/2017

Date registered

18/12/2017

Date last updated

18/12/2017

Type of registration

Prospectively registered

Titles & IDs

Public title

Safety of beta blocker in acute exacerbations of chronic obstructive pulmonary disease (COPD)

Scientific title

Safety of beta blocker commencement during acute exacerbations of chronic obstructive pulmonary disease (COPD) in patients with co-existing cardiovascular disease.

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

COPD

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Obstructive Pulmonary Disease

Cardiovascular disease

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Cardiovascular

Coronary heart disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

All COPD patients who fulfil the inclusion criteria will be given oral metoprolol (ATC C07A B02) 25mg daily for 21 days.

Patients will be assessed on Day 0, 1 and 21 for any side effects from oral metoprolol as well as the effect of metoprolol on spirometry.

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

To assess the safety of commencement of metoprolol in patients admitted with exacerbation of COPD with co-existing cardiovascular diseases, as defined by any adverse events,
Known adverse events from beta blocker includes hypotension, bradycardia, and bronchospasm.
Patients will be monitored for possible adverse events on day 0, 1 and 21 by performing spirometry as well as completion of a St George's Respiratory Questionnaire (SGRQ).

Timepoint [1]

Baseline, Day 1 and Day 21 post metoprolol commencement.

Secondary outcome [1]

To assess the impact of commencement of metoprolol on lung function as measured by post bronchodilator spirometry in patients admitted for exacerbation of COPD.

Timepoint [1]

Baseline, Day 1 and Day 21 post commencement of metoprolol.

Eligibility

Key inclusion criteria

- Age over 18 years
- Primary admission diagnosis of acute exacerbation of COPD
- Moderate to severe COPD (GOLD Class II – III) as defined by spirometry performed prior to admission
- Co-existing cardiovascular diseases with Class I indications, such as IHD, HTN and HFrEF for which beta blocker therapy is indicated.

Minimum age

18 Years

Maximum age

85 Years

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Unwilling to consent
- History of other primary lung disease including asthma, and interstitial lung disease
- Baseline FEV1/FVC greater than 0.7
- Very severe COPD (GOLD IV)
- Illness severity, sufficient to preclude informed consent or completion of the study protocol. Subjects are also excluded if enrolment in the study protocol was likely to interfere with timely medical investigation and treatment
- Severe cognitive impairment
- Physical impairment or social circumstances that would prevent follow up assessments
- Patients with beta blocker allergy or previous documented reactions
- Any degree of heart block
- Already taking a beta blocker or other anti-arrhythmic including calcium channel blocker

Study design

Purpose of the study

Treatment

Allocation to intervention

Non-randomised trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Who is / are masked / blinded?

Intervention assignment

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Paired t-test will be used to examine impact of beta blocker administration on spirometric results.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2018

Actual

Date of last participant enrolment

Anticipated

30/06/2018

Actual

Date of last data collection

Anticipated

23/07/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Northern Hospital - Epping

Recruitment hospital [2]

Austin Health - Austin Hospital - Heidelberg

Recruitment postcode(s) [1]

3076 - Epping

Recruitment postcode(s) [2]

3084 - Heidelberg

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Northern Hospital

Address [1]

185 Cooper Street
EPPING 3076
VIC

Country [1]

Australia

Primary sponsor type

Hospital

Name

Northern Hospital

Address

185 Cooper Street
EPPING 3076
VIC

Country

Australia

Secondary sponsor category [1]

None

Name [1]

None

Address [1]

None

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Austin HREC

Ethics committee address [1]

145 Studley Road
HEIDELBERG 3084
VIC

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/08/2017

Approval date [1]

09/10/2017

Ethics approval number [1]

HREC/17/Austin/321

Summary

Brief summary

Cardiovascular comorbidity is common in patients with COPD. They share cigarette smoking as an important risk factor. However, beta blockers, which are commonly used to treat cardiac diseases, are traditionally avoided in patients with COPD due to the theoretical risk of respiratory adverse events. The aims of this study are:

1. To assess the safety of commencing beta blockers during an acute exacerbation of COPD in individuals with coexistent cardiovascular disease.
2. To assess the impact of commencement of beta blockers on lung function as measure by post bronchodilator spirometry in patients admitted for exacerbation of COPD.

This is a prospective interventional study of individuals admitted with exacerbations of COPD conducted in two metropolitan hospitals in Melbourne. Individuals who are admitted to the Northern and Austin Hospital with acute exacerbations of COPD who have a history of COPD (GOLD Class II – III) and of cardiovascular disease will be invited to participate in the study. When they are considered stable and suitable for participation, the treating team will notify the study coordinator who will consent and enroll the individual in the study.

After signing of the informed consent form, participants who are identified to be ready for discharge the following day will perform spirometry. An initial dose of a cardio-selective beta blocker will be administered and spirometry will be repeated.
Unless an adverse event has occurred, beta blocker administration will continue on the day of discharge, with spirometry repeated. Participants will be reviewed at 21-days post discharge with repeat spirometry. This will be carried out in the Respiratory Outpatient Clinic as is standard practice.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Katharine See

Address

Northern Health
185 Cooper Street
EPPING 3076
VIC

Country

Australia

Phone

+613 8405 8000

Fax

katharine.see@nh.org.au

Contact person for public queries

Name

Katharine See

Address

Northern Health
185 Cooper Street
EPPING 3076
VIC

Country

Australia

Phone

+613 8405 8000

Fax

katharine.see@nh.org.au

Contact person for scientific queries

Name

Katharine See

Address

Northern Health
185 Cooper Street
EPPING 3076
VIC

Country

Australia

Phone

+613 8405 8000

Fax

katharine.see@nh.org.au

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Dimensions AI	Author reply	2018	https://doi.org/10.1111/imj.13700

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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Documents added manually

Documents added automatically