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

• Sponsor: Waikato Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00745043
• Collaborator: Waikato Hospital Research Fund (Other)
• Enrollment: 11
• Location: 1
• Arms: 4
• Duration (Months): 27
• Patients Per Site Per Month: 0.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: bronchodilator response	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 11 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Do Beta-Blockers Affect the Use of Beta-Agonist Inhalers in COPD?
• Study Start Date: May 1, 2005
• Actual Primary Completion Date: Aug 1, 2007
• Actual Study Completion Date: Aug 1, 2007

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Bronchodilator response to salbutamol after beta-blockers [7-10 days]

2. Incremental Shuttle Walk Test Result after taking beta-blockers [7-10 days]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Respiratory Medicine	Hamilton	Waikato	New Zealand	3204

Sponsors and Collaborators

• Waikato Hospital
• Waikato Hospital Research Fund

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00745043
• Other Study ID Numbers: NTX/05/04/035
• First Posted: Sep 1, 2008
• Last Update Posted: Sep 1, 2008
• Last Verified: Aug 1, 2008

• Keywords provided by , ,: COPD; Betablockers; bronchodilator; exercise capacity; methacholine challenge
• Additional relevant MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Bronchodilator Agents

Study Results

No Results Posted as of Sep 1, 2008