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

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ClinicalTrials.gov Identifier: NCT00745043
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
Waikato Hospital Research Fund
Information provided by:
Waikato Hospital

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.

Condition or disease Intervention/treatment
Chronic Obstructive Pulmonary Disease Drug: bronchodilator response

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?
Study Start Date : May 2005
Primary Completion Date : August 2007
Study Completion Date : August 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
U.S. FDA Resources

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Bronchodilator response to salbutamol after beta-blockers [ Time Frame: 7-10 days ]
  2. Incremental Shuttle Walk Test Result after taking beta-blockers [ Time Frame: 7-10 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745043

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

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
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: September 1, 2008
Last Verified: August 2008

Keywords provided by Waikato Hospital:
exercise capacity
methacholine challenge

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