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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Not Applicable
Locations
New Zealand
Study Type
Interventional
Intervention
bronchodilator response
Sponsored by
Waikato Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Betablockers, bronchodilator, exercise capacity, methacholine challenge

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Respiratory Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

R302

R303

R304

Open Label

Arm Description

Daily placebo capsules

Daily metoprolol 95mg capsules

Daily propranolol 80mg capsules

Daily Metoprolol 190mg capsules

Outcomes

Primary Outcome Measures

Bronchodilator response to salbutamol after beta-blockers
Incremental Shuttle Walk Test Result after taking beta-blockers

Secondary Outcome Measures

Full Information

First Posted
August 29, 2008
Last Updated
August 29, 2008
Sponsor
Waikato Hospital
Collaborators
Waikato Hospital Research Fund
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1. Study Identification

Unique Protocol Identification Number
NCT00745043
Brief Title
Beta-Blocker in Chronic Obstructive Pulmonary Disease (COPD) Study
Acronym
BOLD
Official Title
Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
May 2005 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
August 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Waikato Hospital
Collaborators
Waikato Hospital Research Fund

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, Betablockers, bronchodilator, exercise capacity, methacholine challenge

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
R302
Arm Type
Placebo Comparator
Arm Description
Daily placebo capsules
Arm Title
R303
Arm Type
Active Comparator
Arm Description
Daily metoprolol 95mg capsules
Arm Title
R304
Arm Type
Active Comparator
Arm Description
Daily propranolol 80mg capsules
Arm Title
Open Label
Arm Type
Active Comparator
Arm Description
Daily Metoprolol 190mg capsules
Intervention Type
Drug
Intervention Name(s)
bronchodilator response
Primary Outcome Measure Information:
Title
Bronchodilator response to salbutamol after beta-blockers
Time Frame
7-10 days
Title
Incremental Shuttle Walk Test Result after taking beta-blockers
Time Frame
7-10 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bob Hancox, MD FRACP
Organizational Affiliation
Waikato Hospital Research Unit
Official's Role
Study Director
Facility Information:
Facility Name
Department of Respiratory Medicine
City
Hamilton
State/Province
Waikato
ZIP/Postal Code
3204
Country
New Zealand

12. IPD Sharing Statement

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

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