Beta-Blockers for the Prevention of Acute Exacerbations of COPD
This is a multicenter, prospective, randomized, double-blind, placebo-controlled trial that will enroll 1028 patients with at least moderately severe COPD over a three year period and follow them at regular intervals for one year. The primary endpoint is time to first acute exacerbation. Secondary endpoints include rates and severity of COPD exacerbations, cardiovascular events, all-cause mortality, lung function, dyspnea, quality of life and metoprolol-related side effects.
• Male and female subjects, ≥ 40 and less than 85 years of age
• Clinical diagnosis of at least moderate COPD as defined by the Global Initiative for Obstructive Lung Disease (GOLD) criteria (53):
‣ Post bronchodilator FEV1/FVC \< 70% (Forced expiratory volume in 1 second/ forced vital capacity),
⁃ Post bronchodilator FEV1 \< 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
• Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
• To enrich the population for patients who are more likely to have acute exacerbations (54), each subject must meet one or more of the following 4 conditions:
‣ Have a history of receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
⁃ Visiting an Emergency Department for a COPD exacerbation within the past year, or
⁃ Being hospitalized for a COPD exacerbation within the past year
⁃ Be using or be prescribed supplemental oxygen for 12 or more hours per day
⁃ Willingness to make return visits and availability by telephone for duration of study.