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

August 29, 2008
August 29, 2008
May 2005
August 2007   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease
Drug: bronchodilator response
  • Placebo Comparator: R302
    Daily placebo capsules
    Intervention: Drug: bronchodilator response
  • Active Comparator: R303
    Daily metoprolol 95mg capsules
    Intervention: Drug: bronchodilator response
  • Active Comparator: R304
    Daily propranolol 80mg capsules
    Intervention: Drug: bronchodilator response
  • Active Comparator: Open Label
    Daily Metoprolol 190mg capsules
    Intervention: Drug: bronchodilator response
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
August 2007
August 2007   (final data collection date for primary outcome measure)

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
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
New Zealand
 
NCT00745043
NTX/05/04/035
No
Dr Catherina Chang Research Fellow, Respiratory Research Waikato Hospital
Waikato Hospital
Waikato Hospital Research Fund
Study Director: Bob Hancox, MD FRACP Waikato Hospital Research Unit
Waikato Hospital
August 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP