Trial Review

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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] 293436 0
None
Universal Trial Number (UTN)
Trial acronym
COPD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 305606 0
Cardiovascular disease 305607 0
Condition category
Condition code
Respiratory 304827 304827 0 0
Chronic obstructive pulmonary disease
Cardiovascular 304828 304828 0 0
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] 299678 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304036 0
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] 304036 0
Baseline, Day 1 and Day 21 post metoprolol commencement.
Secondary outcome [1] 340776 0
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] 340776 0
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?
No
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
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 9430 0
The Northern Hospital - Epping
Recruitment hospital [2] 9431 0
Austin Health - Austin Hospital - Heidelberg
Recruitment postcode(s) [1] 18140 0
3076 - Epping
Recruitment postcode(s) [2] 18141 0
3084 - Heidelberg

Funding & Sponsors
Funding source category [1] 298066 0
Hospital
Name [1] 298066 0
Northern Hospital
Country [1] 298066 0
Australia
Primary sponsor type
Hospital
Name
Northern Hospital
Address
185 Cooper Street
EPPING 3076
VIC
Country
Australia
Secondary sponsor category [1] 297142 0
None
Name [1] 297142 0
None
Address [1] 297142 0
None
Country [1] 297142 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299082 0
Austin HREC
Ethics committee address [1] 299082 0
145 Studley Road
HEIDELBERG 3084
VIC
Ethics committee country [1] 299082 0
Australia
Date submitted for ethics approval [1] 299082 0
02/08/2017
Approval date [1] 299082 0
09/10/2017
Ethics approval number [1] 299082 0
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 79238 0
Dr Katharine See
Address 79238 0
Northern Health
185 Cooper Street
EPPING 3076
VIC
Country 79238 0
Australia
Phone 79238 0
+613 8405 8000
Fax 79238 0
Email 79238 0
[email protected]
Contact person for public queries
Name 79239 0
Dr Katharine See
Address 79239 0
Northern Health
185 Cooper Street
EPPING 3076
VIC
Country 79239 0
Australia
Phone 79239 0
+613 8405 8000
Fax 79239 0
Email 79239 0
[email protected]
Contact person for scientific queries
Name 79240 0
Dr Katharine See
Address 79240 0
Northern Health
185 Cooper Street
EPPING 3076
VIC
Country 79240 0
Australia
Phone 79240 0
+613 8405 8000
Fax 79240 0
Email 79240 0
[email protected]

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
SourceTitleYear of PublicationDOI
Dimensions AIAuthor reply2018https://doi.org/10.1111/imj.13700
N.B. These documents automatically identified may not have been verified by the study sponsor.