Trial Review

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
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT00745043




Registration number
NCT00745043
Ethics application status
Date submitted
29/08/2008
Date registered
1/09/2008
Date last updated
1/09/2008

Titles & IDs
Public title
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Scientific title
Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?
Secondary ID [1] 0 0
NTX/05/04/035
Universal Trial Number (UTN)
Trial acronym
BOLD
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - bronchodilator response

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


Treatment: Drugs: bronchodilator response
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Bronchodilator response to salbutamol after beta-blockers
Timepoint [1] 0 0
7-10 days
Primary outcome [2] 0 0
Incremental Shuttle Walk Test Result after taking beta-blockers
Timepoint [2] 0 0
7-10 days

Eligibility
Key inclusion criteria
- Clinical diagnosis of COPD

- > 40 years of age

- > 15 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
- Contra-indication to beta-blocker use

- Severe COPD FEV1 < 30% or 1 L

- Not responsive the methacholine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/05/2005
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/08/2007
Sample size
Target
Accrual to date
Final
11
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Waikato

Funding & Sponsors
Primary sponsor type
Other
Name
Waikato Hospital
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Waikato Hospital Research Fund
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00745043
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bob Hancox, MD FRACP
Address 0 0
Waikato Hospital Research Unit
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT00745043