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Trial registered on ANZCTR


Registration number
ACTRN12614001095651
Ethics application status
Approved
Date submitted
22/08/2014
Date registered
15/10/2014
Date last updated
15/10/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Beta-blockers in COPD (Chronic Obstructive Pulmonary Disease): Feasibility of a Randomised Controlled Trial
Scientific title
Beta-blockers in COPD: Feasibility of a Randomised Controlled Trial
Secondary ID [1] 285207 0
None
Universal Trial Number (UTN)
U1111-1157-1547
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD)
292823 0
Condition category
Condition code
Respiratory 293123 293123 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Feasibility of starting a cardioselective beta-blocker (metoprolol) in patients with an exacerbation of COPD. Participants will be given a test dose of 12.5 mg standard oral metoprolol in hospital. If this is tolerated, they will be commenced on a low dose of 23.75mg controlled-release metoprolol on daily. The dose will be increased after two weeks to 47.5mg daily and after a further 4 weeks to 95mg daily if tolerated. The duration of treatment will be 3 months.
Intervention code [1] 290081 0
Prevention
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 292985 0
Whether participants tolerate beta-blocker treatment according to patients and clinician judgement. Patients may be able to tolerate a lower dose of beta-blocker, but not the target dose of 95mg. The primary outcome is whether beta-blocker therapy is stopped completely.
Timepoint [1] 292985 0
3 months
Secondary outcome [1] 310083 0
Adverse effects. These include acute bronchospasm, postural dizziness, falls, severe bradycardia, heart block. Symptoms will be recorded, ECG, spirometry, blood pressure and pulse will be measured at each clinic assessment prior to each dose increase.
Timepoint [1] 310083 0
3 months

Eligibility
Key inclusion criteria
Admitted to hospital with an exacerbation of COPD
Spirometry confirms COPD
At least 10 pack year smoking history
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Acute coronary syndrome
Already treated with beta-blocker
Major contra-indication to cardio-selective beta-blocker
Terminal illness
Primary admission diagnosis of pneumonia or other acute respiratory disease

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Eligible participants who consent to take part will be enrolled. All participants will receive active treatment: this is a feasibility study to determine if a larger randomised-controlled trial can be done.
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
Not Applicable
Type of endpoint(s)
Safety
Statistical methods / analysis
Descriptive only

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 6305 0
New Zealand
State/province [1] 6305 0

Funding & Sponsors
Funding source category [1] 289823 0
Government body
Name [1] 289823 0
Health Research Council (NZ)
Address [1] 289823 0
Level 3,
110 Stanley Street,
Auckland 1010.

PO Box 5541,
Wellesley Street,
Auckland 1141.
Country [1] 289823 0
New Zealand
Primary sponsor type
Individual
Name
Robert Hancox
Address
Department of Preventive and Social Medicine,
Dunedin School of Medicine,
University of Otago,
PO Box 56,
Dunedin
9054

Country
New Zealand
Secondary sponsor category [1] 288515 0
University
Name [1] 288515 0
University of Otago
Address [1] 288515 0
PO Box 56,
Dunedin,
9054
Country [1] 288515 0
New Zealand
Other collaborator category [1] 278124 0
Individual
Name [1] 278124 0
Dr Catherina Chang
Address [1] 278124 0
Department of Respiratory Medicine,
Waikato Hospital,
Pembroke Street,
Hamilton 3240
Country [1] 278124 0
New Zealand
Other collaborator category [2] 278125 0
Individual
Name [2] 278125 0
Associate Professor Lutz Beckert
Address [2] 278125 0
Department of Medicine
University of Otago
2 Riccarton Avenue,
PO Box 4345,
Christchurch 8140
Country [2] 278125 0
New Zealand
Other collaborator category [3] 278126 0
Individual
Name [3] 278126 0
Professor Richard Beasley
Address [3] 278126 0
Medical Research Institute of New Zealand/Capital Coast DHB,
Private Bag 7902, Newtown
Wellington 6242
Country [3] 278126 0
New Zealand
Other collaborator category [4] 278127 0
Individual
Name [4] 278127 0
Dr Kyle Perrin
Address [4] 278127 0
Department of Medicine
University of Otago
23A Mein St, Newtown.
Wellington 6021
Country [4] 278127 0
New Zealand
Other collaborator category [5] 278128 0
Individual
Name [5] 278128 0
Dr Conroy Wong
Address [5] 278128 0
Department of Respiratory Medicine
Middlemore Hospital
Otahuhu
Private Bag 93311
Auckland 2025
Country [5] 278128 0
New Zealand
Other collaborator category [6] 278129 0
Individual
Name [6] 278129 0
Associate Professor Robert Young
Address [6] 278129 0
Department of Medicine
University of Auckland/Auckland DHB
Auckland City Hospital
Private Bag 92019
Auckland 1142
Country [6] 278129 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291556 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 291556 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 291556 0
New Zealand
Date submitted for ethics approval [1] 291556 0
Approval date [1] 291556 0
09/07/2014
Ethics approval number [1] 291556 0
14/NTB/88

Summary
Brief summary
Beta-blocker treatment is known to improve survival from several cardiac diseases. Unfortunately, beta-blockers are usually avoided in patients with chronic obstructive pulmonary disease (COPD) because of concerns that they may make airflow obstruction worse. Therefore patients with COPD are often deprived of the benefits of beta-blockers even though they have a very high risk of cardiac problems. Recent evidence suggests that beta-blockers may be safe and effective in lung disease but there have been no clinical studies to confirm this. This feasibility study will assess the safety and tolerability of metoprolol, a cardio-selective beta-blocker, in patients with exacerbations of COPD to determine whether a randomised controlled trial of beta-blockers should be conducted. The randomised study would provide a definitive answer on whether beta-blockers are safe and effective in patients with chronic obstructive pulmonary disease.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 50854 0
A/Prof Robert Hancox
Address 50854 0
Department of Preventive and Social Medicine,
Dunedin School of Medicine,
P.O. Box 913
University of Otago,
Dunedin.
9054
Country 50854 0
New Zealand
Phone 50854 0
+64 3 4798512
Fax 50854 0
Email 50854 0
bob.hancox@otago.ac.nz
Contact person for public queries
Name 50855 0
A/Prof Robert Hancox
Address 50855 0
Department of Preventive and Social Medicine,
Dunedin School of Medicine,
P.O. Box 913
University of Otago,
Dunedin.
9054
Country 50855 0
New Zealand
Phone 50855 0
+64 3 4798512
Fax 50855 0
Email 50855 0
bob.hancox@otago.ac.nz
Contact person for scientific queries
Name 50856 0
A/Prof Robert Hancox
Address 50856 0
Department of Preventive and Social Medicine,
Dunedin School of Medicine,
P.O. Box 913
University of Otago,
Dunedin.
9054
Country 50856 0
New Zealand
Phone 50856 0
+64 3 4798512
Fax 50856 0
Email 50856 0
bob.hancox@otago.ac.nz

No data has been provided for results reporting
Summary results
Not applicable