Clinical Research Directory

Beta-blockers to Patients With Chronic Obstructive Pulmonary Disease

Sponsor: Ole Frobert, MD, PhD

Summary

Background: In patients with chronic obstructive pulmonary disease (COPD) and concomitant cardiovascular conditions cardio-selective beta-blockers reduce mortality and can be used without significant negative effects on lung function or respiratory symptoms. Observational studies indicate that beta-blocker therapy in COPD even without overt cardiovascular disease, is associated with reduced risk for mortality and COPD exacerbations. Aim: The overall purpose of our study is to examine the benefit of general beta-blocker therapy on important patient-oriented measures in chronic obstructive pulmonary disease (COPD). Our primary hypothesis that treatment with beta-blockers in patients with COPD and no comorbid heart disease at baseline can prevent a Composite measure of hospitalizations due to cardiovascular diseases, COPD exacerbations and death. Population: 1700 patients with C OPD. Inclusion criteria are FEV1/FVC \< 70, age \>40 years and sinus rhythm 50-120/min. Exclusion criteria include hypersensitivity against metoprolol, atrioventricular (AV) block II or II or sick sinus syndrome without pacemaker, atrial fibrillation or flutter, clinical signs of or previously known cardiovascular disease, systolic blood pressure \< 90, severe asthma, present beta-blocker therapy or ongoing COPD exacerbation. Intervention: Metoprolol at a target dose of 100 mg in addition to standard COPD care. Control: No placebo control. Randomized, pragmatic un-blinded controlled study where the control Group receives standard COPD care. Outcome: The primary outcome is a composite measure of all-cause mortality, C OPD exacerbations, and cardiovascular events after one year. Endpoint data from Swedish national registries and clinical follow-up. Importance: Beta-blocker treatment to attenuate morbidity in patients with COPD could have great clinical and social importance at a low cost.

Official title: Beta-blockeRs tO patieNts With CHronIc Obstructive puLmonary diseasE

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