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Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study (BOLD)

This study has been completed.
Sponsor:
Collaborator:
Waikato Hospital Research Fund
Information provided by:
Waikato Hospital
ClinicalTrials.gov Identifier:
NCT00745043
First received: August 29, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  Purpose

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.


Condition Intervention
Chronic Obstructive Pulmonary Disease
 Drug: bronchodilator response

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Waikato Hospital:

Primary Outcome Measures:
  • Bronchodilator response to salbutamol after beta-blockers [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]
  • Incremental Shuttle Walk Test Result after taking beta-blockers [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: May 2005
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: R302
Daily placebo capsules
 Drug: bronchodilator response
Active Comparator: R303
Daily metoprolol 95mg capsules
 Drug: bronchodilator response
Active Comparator: R304
Daily propranolol 80mg capsules
 Drug: bronchodilator response
Active Comparator: Open Label
Daily Metoprolol 190mg capsules
 Drug: bronchodilator response

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of COPD
  • > 40 years of age
  • > 15 pack year smoking history

Exclusion Criteria:

  • Contra-indication to beta-blocker use
  • Severe COPD FEV1 < 30% or 1 L
  • Not responsive the methacholine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00745043

Locations
New Zealand
Department of Respiratory Medicine
Hamilton, Waikato, New Zealand, 3204
Sponsors and Collaborators
Waikato Hospital
Waikato Hospital Research Fund
Investigators
Study Director: Bob Hancox, MD FRACP Waikato Hospital Research Unit
  More Information

No publications provided

Responsible Party: Dr Catherina Chang Research Fellow, Respiratory Research Waikato Hospital
ClinicalTrials.gov Identifier: NCT00745043     History of Changes
Other Study ID Numbers: NTX/05/04/035
Study First Received: August 29, 2008
Last Updated: August 29, 2008
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by Waikato Hospital:
COPD
Betablockers
bronchodilator
exercise capacity
methacholine challenge

Additional relevant MeSH terms:
Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Adrenergic beta-Antagonists
Bronchodilator Agents
Adrenergic Antagonists
Adrenergic Agents
 Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 18, 2013