ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12616000839404

Ethics application status

Approved

Date submitted

21/06/2016

Date registered

28/06/2016

Date last updated

31/01/2018

Type of registration

Prospectively registered

Titles & IDs

Public title

Beta-blockers in chronic obstructive pulmonary disease (COPD): Feasibility study

Scientific title

Beta-blockers in COPD: Feasibility of an RCT in stable patients

Secondary ID [1]

nil

Universal Trial Number (UTN)

U1111-1182-7193

Trial acronym

Linked study record

Health condition

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

COPD

Condition category

Condition code

Respiratory

Chronic obstructive pulmonary disease

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

A feasibility study to assess whether cardio-selective beta-blockers can be started in patients with stable COPD. If patients can tolerate the drug, this will inform future randomised, placebo-controlled trial.
Oral bisoprolol will be started at a dose of 1.25mg daily, increased to 2.5mg daily after 2 weeks and to a target dose of 5mg daily after a further 4 weeks if tolerated. This dose will be maintained for a further 6 weeks.
Compliance will not be objectively monitored

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Ability to recruit eligible patients - percent of eligible patients screened who are started on the beta-blocker

Timepoint [1]

one year

Primary outcome [2]

Proportion of patients who tolerate cardio-selective beta-blockers, judged by the proportion of participants who remain on the beta-blockers at the end of the study (self-report).

Timepoint [2]

3 months after starting drug

Secondary outcome [1]

Proportion of patients who reach the target dose of 5mg bisoprolol once daily. Assessed by the number of participants who are dispensed the drug and report taking it.

Timepoint [1]

3 months after starting drug

Secondary outcome [2]

Proportion of patients experiencing beta-blocker related adverse events and description of these adverse events.
All adverse events will be noted: these events will be detected by self-report, clinical notes, third-party reports (e.g. other doctors or coroner) and/or clinical observations at follow-up,
Pulse, blood pressure, spirometry, and ECGs will be done at each follow-up visit to record the cardiovascular and airway effects of the drug.

Timepoint [2]

3 months after starting drug

Eligibility

Key inclusion criteria

Clinical diagnosis of COPD
FEV1/FVC ratio <70% on spirometery
History of COPD exacerbation in previous 2 years
Currently clinically stable

Minimum age

40 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Clinical diagnosis of asthma
Contraindication to beta-blockers
Active cancer or terminal illness
Pregnant or breastfeeding
Acute coronary syndrome

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)

None

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

not applicable

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Single group

Other design features

Phase

Type of endpoint/s

Safety

Statistical methods / analysis

Descriptive analysis of the proportions of patients able to be recruited, the number who tolerate the beta-blocker drug, and the number experiencing adverse events.

Recruitment

Recruitment status

Active, not recruiting

Date of first participant enrolment

Anticipated

1/08/2016

Actual

29/11/2016

Date of last participant enrolment

Anticipated

30/06/2017

Actual

27/11/2017

Date of last data collection

Anticipated

30/03/2018

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Health Research Council

Address [1]

Level 3, 110 Stanley St, Auckland, New Zealand.

1141

Country [1]

New Zealand

Primary sponsor type

Individual

Name

Robert Hancox

Address

Dunedin School of Medicine,
University of Otago,
PO Box 913
Dunedin.
New Zealand

9054

Country

New Zealand

Secondary sponsor category [1]

Individual

Name [1]

Catherina Chang

Address [1]

Department of Respiratory Medicine
Waikato Hospital
Pembroke St
Hamilton

3240

Country [1]

New Zealand

Other collaborator category [1]

Individual

Name [1]

Lutz Beckert

Address [1]

Department of Medicine
University of Otago,
PO Box 4345
Christchurch

8140

Country [1]

New Zealand

Other collaborator category [2]

Individual

Name [2]

Richard Beasley

Address [2]

Medical Research Institute of New Zealand
Level 7, CSB building,
Riddiford St,
Private Bag 7902
Wellington

6021

Country [2]

New Zealand

Other collaborator category [3]

Individual

Name [3]

Conroy Wong

Address [3]

Middlemore Hospital,
100 Hospital Road,
Papatoetoe,
Auckland

2025

Country [3]

New Zealand

Other collaborator category [4]

Individual

Name [4]

Catherina Chang

Address [4]

Department of Respiratory Medicine
Waikato Hospital
Pembroke St
Hamilton

3240

Country [4]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Southern Health & Disability Ethics Committee

Ethics committee address [1]

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/06/2016

Approval date [1]

03/08/2016

Ethics approval number [1]

Summary

Brief summary

Rationale for Research
Cardiac diseases are a major cause of death in patients with chronic obstructive pulmonary disease (COPD). Patients with exacerbations of COPD are at risk of cardiac complications and these may be the most important determinant of survival in these patients. In addition, both of the commonly used classes of bronchodilators may increase cardiovascular risk and are used in high doses during exacerbations. Protecting patients with exacerbations of COPD from cardiac complications may have a greater impact on mortality than existing respiratory treatments. Beta-blockers are a valuable class of drug for protecting the heart and retrospective studies suggest that beta-blockers could reduce mortality in COPD. However patients with COPD have been excluded from prospective clinical trials of beta-blockers and continue to be denied treatment with them because of concerns that they may worsen airways disease. Several observational studies suggest that beta-blockers are safe and that they reduce mortality in patients with COPD. However, these studies have been prone to bias and confounding. 
We recently completed a study to assess the feasibility of conducting an RCT of beta-blockers in patients in hospital with exacerbations of COPD. It became clear that we could not do an RCT in this setting. Our aim now to assess whether it is feasible to do an RCT in stable patients with a history of COPD exacerbations
Aims
Before we conduct a randomised placebo-controlled trial of the cardio-selective beta-blocker metoprolol in patients with stable COPD, we are doing this feasibility study to explore two practical aspects of the proposed study:  
1.	Can beta-blockers be safely commenced in patients with a history of exacerbations of COPD? Although some patients with COPD take regular beta-blockers, it is not known what proportion of patients will be able to tolerate them. We aim to recruit 48 patients (12 in 4 centres) to establish whether cardio-selective beta-blockers can be commenced in patients with a history of exacerbations and what proportion of them tolerate the drug. 
2.	What proportion of patients with a history of exacerbations of COPD will be eligible for recruitment, how many consent to take part, how many will be excluded for reasons such as contra-indications to beta-blocker (e.g. childhood asthma, peripheral vascular disease), pre-existing beta-blocker treatment, or have other medical conditions such as advanced malignancy and would be unlikely to benefit from beta-blockers? This information will be important for planning recruitment to the main study.
Protocol
This feasibility study will recruit patents with COPD and start them on a low dose of metoprolol increasing to a target dose of 95mg daily over 6 weeks. The study will finish after 3 months - after 6 weeks on the highest dose.

Trial website

None

Trial related presentations / publications

None

Public notes

None

Contacts

Principal investigator

Name

A/Prof Bob Hancox

Address

Dept of Preventive & Social Medicine
Dunedin School of Medicine
PO Box 913
University of Otago

9054

Country

New Zealand

Phone

+6434798512

Fax

bob.hancox@otago.ac.nz

Contact person for public queries

Name

Bob Hancox

Address

Dept of Preventive & Social Medicine
Dunedin School of Medicine
PO Box 913
University of Otago

9054

Country

New Zealand

Phone

+6434798512

Fax

bob.hancox@otago.ac.nz

Contact person for scientific queries

Name

Bob Hancox

Address

Dept of Preventive & Social Medicine
Dunedin School of Medicine
PO Box 913
University of Otago

9054

Country

New Zealand

Phone

+6434798512

Fax

bob.hancox@otago.ac.nz

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

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Documents added automatically

No additional documents have been identified.

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