a study on Chronic Obstructive Pulmonary Disease
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.
Beta-Blockers for the Prevention of Acute Exacerbations of COPD
Hypothesis The primary hypothesis is that metoprolol succinate will reduce the risk of COPD exacerbations as compared to placebo. The secondary hypothesis is that metoprolol succinate will not adversely impact lung function, exercise tolerance, dyspnea or quality of life as compared to placebo.
Study Flow Patients will be screened and then randomized over a 2 week period and will then undergo a dose titration period for the following six weeks. Thereafter patients will be followed for 42 additional weeks on their target dose of metoprolol or placebo followed by a 4 week washout period.
Primary: To determine the effect of once daily metoprolol succinate compared with placebo on the time to first exacerbation in moderate to severe COPD patients who are prone to exacerbations and who do not have absolute indications for beta-blocker therapy.
Secondary: To estimate the effect of metoprolol succinate compared with placebo on:
Secondary subgroup analyses for 1) cardiovascular risk based on Personal HEART Score and 2) age greater versus less than 65.
Pulmonary Disease, Chronic Obstructive Chronic Obstructive Pulmonary Disease COPD Exacerbation Lung function Cardiac Cardiovascular Beta blockers Metoprolol succinate Smoking Metoprolol Adrenergic beta-Antagonists
Open to people ages 40 years to 84 years
Obstructive Lung Disease (GOLD) criteria (53):
Post bronchodilator FEV1 < 80% predicted, with or without chronic symptoms(i.e., cough, sputum production).
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