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

August 29, 2008 updated by: Waikato Hospital

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • New Zealand
    • Waikato
      • Hamilton, Waikato, New Zealand, 3204
        • Department of respiratory medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Bronchodilator response to salbutamol after beta-blockers
Time Frame: 7-10 days
7-10 days
Incremental Shuttle Walk Test Result after taking beta-blockers
Time Frame: 7-10 days
7-10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Waikato Hospital

Collaborators

Waikato Hospital Research Fund

Investigators

  • Study Director: Bob Hancox, MD FRACP, Waikato Hospital Research Unit

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2005

Primary Completion (ACTUAL)

August 1, 2007

Study Completion (ACTUAL)

August 1, 2007

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (ESTIMATE)

September 1, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

September 1, 2008

Last Update Submitted That Met QC Criteria

August 29, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NTX/05/04/035

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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