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

Chronic Obstructive Pulmonary Disease Clinical Trial

— BOLD  

Official title:

Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745043
• Other study ID #: NTX/05/04/035
• Status: Completed
• Phase: N/A
• First received: August 29, 2008
• Last updated: August 29, 2008
• Start date: May 2005
• Est. completion date: August 2007

Study information

• Verified date: August 2008
• Source: Waikato Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• bronchodilator response

Locations

Country	Name	City	State
New Zealand	Department of Respiratory Medicine	Hamilton	Waikato

Sponsors (2)

Lead Sponsor	Collaborator
Waikato Hospital	Waikato Hospital Research Fund

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bronchodilator response to salbutamol after beta-blockers		7-10 days	Yes
Primary	Incremental Shuttle Walk Test Result after taking beta-blockers		7-10 days	No