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

This study has been completed.

Sponsors and Collaborators: Waikato Hospital
Waikato Hospital Research Fund
Information provided by: Waikato Hospital
ClinicalTrials.gov Identifier: NCT00745043
  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

MedlinePlus related topics:   COPD (Chronic Obstructive Pulmonary Disease)    Exercise and Physical Fitness   

Drug Information available for:   Methacholine    Methacholine chloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Safety/Efficacy Study
Official Title:   Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?

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
R302: Placebo Comparator
Daily placebo capsules
Drug: bronchodilator response
R303: Active Comparator
Daily metoprolol 95mg capsules
Drug: bronchodilator response
R304: Active Comparator
Daily propranolol 80mg capsules
Drug: bronchodilator response
Open Label: Active Comparator
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, Waikato
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


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

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

Study placed in the following topic categories:
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Methacholine Chloride
Pulmonary Disease, Chronic Obstructive

ClinicalTrials.gov processed this record on October 24, 2008




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