Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00745043
Registration number
NCT00745043
Ethics application status
Date submitted
29/08/2008
Date registered
1/09/2008
Date last updated
29/07/2024
Titles & IDs
Public title
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Query!
Scientific title
Do Beta-blockers Affect the Use of Beta-agonist Inhalers in COPD?
Query!
Secondary ID [1]
0
0
NTX/05/04/035
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
BOLD
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
0
0
Query!
Condition category
Condition code
Respiratory
0
0
0
0
Query!
Chronic obstructive pulmonary disease
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Placebo comparator: R302 - Daily placebo capsules
Active comparator: R303 - Daily metoprolol 95mg capsules
Active comparator: R304 - Daily propranolol 80mg capsules
Active comparator: Open Label - Daily Metoprolol 190mg capsules
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Bronchodilator response to salbutamol after beta-blockers
Query!
Assessment method [1]
0
0
Query!
Timepoint [1]
0
0
7-10 days
Query!
Primary outcome [2]
0
0
Incremental Shuttle Walk Test Result after taking beta-blockers
Query!
Assessment method [2]
0
0
Query!
Timepoint [2]
0
0
7-10 days
Query!
Eligibility
Key inclusion criteria
* Clinical diagnosis of COPD
* > 40 years of age
* > 15 pack year smoking history
Query!
Minimum age
40
Years
Query!
Query!
Maximum age
100
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
* Contra-indication to beta-blocker use
* Severe COPD FEV1 < 30% or 1 L
* Not responsive the methacholine
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
The people receiving the treatment/s
The people analysing the results/data
Query!
Query!
Query!
Query!
Intervention assignment
Crossover
Query!
Other design features
Query!
Phase
NA
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/05/2005
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
1/08/2007
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
11
Query!
Recruitment in Australia
Recruitment state(s)
Query!
Recruitment outside Australia
Country [1]
0
0
New Zealand
Query!
State/province [1]
0
0
Waikato
Query!
Funding & Sponsors
Primary sponsor type
Other
Query!
Name
Waikato Hospital
Query!
Address
Query!
Country
Query!
Other collaborator category [1]
0
0
Other
Query!
Name [1]
0
0
Waikato Hospital Research Fund
Query!
Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief summary
Smoking causes both smoking related lung disease (COPD) and ischaemic heart disease. These are very common conditions and many patients have both diseases. Beta-blocker drugs are extensively used in the treatment of angina, high blood pressure and after heart attacks to decrease symptoms and prolong life. Beta-agonists are used in COPD to decrease breathlessness and improve exercise tolerance. It used to be thought that beta-blockers cannot be used in COPD patients as they may make the breathlessness worse, but it has now been established that they can be used safely. Beta-blocker drugs and beta-agonists have 'opposite' effects on the body and the investigators do not know if they can work together or if they would cancel each other out. The investigators also do not know which of the different types of beta-blockers now available are better for COPD patients. This study will investigate what happens to the airways of people taking both of these drugs.
Query!
Trial website
https://clinicaltrials.gov/study/NCT00745043
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Bob Hancox, MD FRACP
Query!
Address
0
0
Waikato Hospital Research Unit
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
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
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT00745043
Download to PDF