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Trial record 6 of 7 for:    "Lung Disease" | "Metoprolol"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00745043
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : September 1, 2008
Sponsor:
Collaborator:
Waikato Hospital Research Fund
Information provided by:
Waikato Hospital

Tracking Information
First Submitted Date  ICMJE August 29, 2008
First Posted Date  ICMJE September 1, 2008
Last Update Posted Date September 1, 2008
Study Start Date  ICMJE May 2005
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2008)
  • Bronchodilator response to salbutamol after beta-blockers [ Time Frame: 7-10 days ]
  • Incremental Shuttle Walk Test Result after taking beta-blockers [ Time Frame: 7-10 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Official Title  ICMJE Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Chronic Obstructive Pulmonary Disease
Intervention  ICMJE Drug: bronchodilator response
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 29, 2008)
11
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2007
Actual Primary Completion Date August 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE New Zealand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00745043
Other Study ID Numbers  ICMJE NTX/05/04/035
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Catherina Chang Research Fellow, Respiratory Research Waikato Hospital
Study Sponsor  ICMJE Waikato Hospital
Collaborators  ICMJE Waikato Hospital Research Fund
Investigators  ICMJE
Study Director: Bob Hancox, MD FRACP Waikato Hospital Research Unit
PRS Account Waikato Hospital
Verification Date August 2008

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