Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
BOLD
Do Beta-blockers Affect the Use of Beta-agonist Inhalers in COPD?
1 other identifier
interventional
11
1 country
1
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable chronic-obstructive-pulmonary-disease
Started May 2005
Typical duration for not_applicable chronic-obstructive-pulmonary-disease
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedFirst Submitted
Initial submission to the registry
August 29, 2008
CompletedFirst Posted
Study publicly available on registry
September 1, 2008
CompletedJuly 29, 2024
August 1, 2008
2.3 years
August 29, 2008
July 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Bronchodilator response to salbutamol after beta-blockers
7-10 days
Incremental Shuttle Walk Test Result after taking beta-blockers
7-10 days
Study Arms (4)
R302
PLACEBO COMPARATORDaily placebo capsules
R303
ACTIVE COMPARATORDaily metoprolol 95mg capsules
R304
ACTIVE COMPARATORDaily propranolol 80mg capsules
Open Label
ACTIVE COMPARATORDaily Metoprolol 190mg capsules
Interventions
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of COPD
- \> 40 years of age
- \> 15 pack year smoking history
You may not qualify if:
- Contra-indication to beta-blocker use
- Severe COPD FEV1 \< 30% or 1 L
- Not responsive the methacholine
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Waikato Hospitallead
- Waikato Hospital Research Fundcollaborator
Study Sites (1)
Department of Respiratory Medicine
Hamilton, Waikato Region, 3204, New Zealand
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Bob Hancox, MD FRACP
Waikato Hospital Research Unit
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 1, 2008
Study Start
May 1, 2005
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
July 29, 2024
Record last verified: 2008-08