Trial Review

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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
Sex
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
17/10/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
48
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)
Country [1] 289823 0
New Zealand
Primary sponsor type
Individual
Name
Robert Hancox
Country
New Zealand
Secondary sponsor category [1] 288515 0
University
Name [1] 288515 0
University of Otago
Country [1] 288515 0
New Zealand
Other collaborator category [1] 278124 0
Individual
Name [1] 278124 0
Dr Catherina Chang
Country [1] 278124 0
New Zealand
Other collaborator category [2] 278125 0
Individual
Name [2] 278125 0
Associate Professor Lutz Beckert
Country [2] 278125 0
New Zealand
Other collaborator category [3] 278126 0
Individual
Name [3] 278126 0
Professor Richard Beasley
Country [3] 278126 0
New Zealand
Other collaborator category [4] 278127 0
Individual
Name [4] 278127 0
Dr Kyle Perrin
Country [4] 278127 0
New Zealand
Other collaborator category [5] 278128 0
Individual
Name [5] 278128 0
Dr Conroy Wong
Country [5] 278128 0
New Zealand
Other collaborator category [6] 278129 0
Individual
Name [6] 278129 0
Associate Professor Robert Young
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
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
Trial website
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
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
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 information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23351Other  bob.hancox@otago.ac.nz
23813Other    Documents will be made available on reasonable req... [More Details]

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 AIß-blockers in exacerbations of COPD: feasibility of a randomised controlled trial2017https://doi.org/10.1183/23120541.00090-2016
N.B. These documents automatically identified may not have been verified by the study sponsor.