Beta-blockers in chronic obstructive pulmonary disease (COPD): Feasibility study

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Rationale for Research Cardiac diseases are a major cause of death in patients with chronic obstructive pulmonary disease (COPD). Patients with exacerbations of COPD are at risk of cardiac complications and these may be the most important determinant of survival in these patients. In addition, both of the commonly used classes of bronchodilators may increase cardiovascular risk and are used in high doses during exacerbations. Protecting patients with exacerbations of COPD from cardiac complications may have a greater impact on mortality than existing respiratory treatments. Beta-blockers are a valuable class of drug for protecting the heart and retrospective studies suggest that beta-blockers could reduce mortality in COPD. However patients with COPD have been excluded from prospective clinical trials of beta-blockers and continue to be denied treatment with them because of concerns that they may worsen airways disease. Several observational studies suggest that beta-blockers are safe and that they reduce mortality in patients with COPD. However, these studies have been prone to bias and confounding. We recently completed a study to assess the feasibility of conducting an RCT of beta-blockers in patients in hospital with exacerbations of COPD. It became clear that we could not do an RCT in this setting. Our aim now to assess whether it is feasible to do an RCT in stable patients with a history of COPD exacerbations Aims Before we conduct a randomised placebo-controlled trial of the cardio-selective beta-blocker metoprolol in patients with stable COPD, we are doing this feasibility study to explore two practical aspects of the proposed study: 1. Can beta-blockers be safely commenced in patients with a history of exacerbations of COPD? Although some patients with COPD take regular beta-blockers, it is not known what proportion of patients will be able to tolerate them. We aim to recruit 48 patients (12 in 4 centres) to establish whether cardio-selective beta-blockers can be commenced in patients with a history of exacerbations and what proportion of them tolerate the drug. 2. What proportion of patients with a history of exacerbations of COPD will be eligible for recruitment, how many consent to take part, how many will be excluded for reasons such as contra-indications to beta-blocker (e.g. childhood asthma, peripheral vascular disease), pre-existing beta-blocker treatment, or have other medical conditions such as advanced malignancy and would be unlikely to benefit from beta-blockers? This information will be important for planning recruitment to the main study. Protocol This feasibility study will recruit patents with COPD and start them on a low dose of metoprolol increasing to a target dose of 95mg daily over 6 weeks. The study will finish after 3 months - after 6 weeks on the highest dose.

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