Beta Blocker Therapy in Moderate to Severe COPD

• Status: Completed
• Trial end date: 2016-07-01
• Target enrollment: 0
• Participant gender: All

Summary

Beta blockers are a type of medication mainly used for heart disease. They are commonly used to treat 'angina' and to prevent heart attacks. Patients with COPD are more likely to suffer from heart disease and so already benefit from this treatment for this reason. In addition to this, new research suggests that there may be further benefit of using beta blockers for COPD, even without also having heart disease.

The reason why beta blockers are not widely used in COPD at present is because of their potential to make symptoms of COPD worse by causing the airways to narrow. Beta blockers are the opposite type of medication to 'beta-agonists' such as salbutamol which you may be taking for symptoms of breathlessness or wheezing. Nevertheless beta blockers are still used in COPD where the benefits (for example heart disease) outweigh any risks.

Current COPD treatment includes inhaled steroids and long acting beta agonists, often given in a combination inhaler (e.g. Seretide or Symbicort) to treat both airway inflammation and airway narrowing, leading to improvement in symptoms. Another drug commonly used is Tiotropium (Spiriva) which is another type of long acting inhaler medication to help with widening the airways.

In this study, we wish to find out if two different types of beta blocker cause different effects on the airways in COPD patients. One type of beta blocker is more 'selective' in acting mainly on the heart, with the other type having more general or 'non-selective' effects on both the heart and lungs. By doing this we will also be able to look at how the beta blockers work alongside the 'usual' inhaler treatment described above.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Dundee
• Collaborator: Tenovus Scotland
• Treatments: Beclomethasone; Bisoprolol; Carvedilol; Formoterol Fumarate; Tiotropium Bromide

Criteria

Inclusion Criteria:

• Moderate to severe COPD (GOLD stage 2 and 3)

• FEV1 30-80% predicted

• No exacerbation in previous 3 months

• Smoking history ≥ 10 pack years

• Oxygen saturations≥ 92% on room air at rest

• ECG demonstrating sinus rhythm

Exclusion Criteria:

• Use of domiciliary oxygen

• History of other primary obstructive lung disease including asthma or bronchiectasis

• History of unstable angina, uncontrolled hypertension or heart failure NYHA class 3-4

• Overt clinical signs of right heart failure

• Average resting systolic BP<110mmHg

• Average resting HR<60bpm

• Pregnancy or lactation

• Known or suspected sensitivity to/intolerance of investigational medicinal product

• Inability to comply with compulsory aspects of protocol

• Any degree of heart block

• Concomitant prescription of beta-blockers, rate-limiting calcium channel blockers, digoxin or amiodarone

• Any clinically significant medical condition that may endanger the health or safety of the participant, or jeopardise the protocol

• Participation in another trial within the previous 30 days