Beta Blockers for the Prevention of Acute Exacerbations of COPD
Abstract
In the proposed study, we will examine the potential role of beta-blockers in the treatment of chronic obstructive pulmonary disease (COPD). COPD is the most common lower respiratory tract disorder in the United States, which is one of the Fiscal Year 2014 Peer Reviewed Medical Research Program Topic Areas. COPD recently surpassed stroke as the third leading cause of death in the United States and is among the most costly chronic illnesses in terms of total medical spending, missed work, and disability. COPD is most commonly caused by cigarette smoking, though exposure to dusts and toxic chemicals at work or in the community where patients live can also lead to the disease. COPD leads to obstruction of the airways, which in turn causes a number of symptoms including cough and shortness of breath. Shortness of breath progresses over time and patients have more and more trouble exerting themselves. When the disease is very severe, they can have trouble with simple tasks including bathing and walking around their house. Patients with COPD are also at risk for a number of other serious illnesses including depression, lung cancer, and perhaps most importantly, coronary artery disease and can lead to heart attacks, abnormal heart rhythms, and heart failure. Though COPD usually worsens slowly over years, many patients have episodes where their symptoms acutely worsen -- termed acute exacerbations of COPD. These exacerbations are commonly caused by viral or bacterial infections or by exposure to increased levels of pollution, but some can be caused or made worse by underlying cardiovascular disease, which may or may not have been diagnosed. Exacerbations lead to more than 500,000 hospitalizations each year and are the major contributor to the overall costs of the disease. Though existing treatments can improve symptoms, quality of life, and modestly reduce the risk of acute exacerbations, none decrease the risk of death. We know from prior studies that beta-blockers reduce the risk of cardiovascular-related deaths in patients with and without COPD, but the drugs are often not used in those with COPD because many doctors have concerns about the potential for them to cause constriction of the airways and acutely worsen lung function. This practice continues despite the fact that the drugs are usually well tolerated in patients with COPD and more recent data have been published, suggesting that they may also reduce the risk of exacerbations. Though these new data are promising, a large placebo-controlled trial is needed to definitively prove that beta-blockers are safe in patients with COPD and that they do in fact reduce the risk of exacerbations. If this were proven, it would dramatically alter COPD treatment recommendations. The major objective of the study is to determine whether a beta-blocker, in this case a once daily dose of metoprolol succinate can reduce the risk of acute exacerbations of COPD and whether patients can take the drug without major side effects. The study is designed as a placebo-controlled trial meaning half the patients who qualify for the study will be randomly assigned by a computer to receive either the beta-blocker or a similar appearing pill but with no active drug inside. The study will be carried out at research centers across the United States including civilian and Veterans Affairs hospitals and will enroll approximately 1,000 patients. The study will enroll patients who have at least moderately severe COPD as shown by lung function tests, though will also include patients with very severe disease who may be on oxygen. Patients with some medical problems that are very serious and may increase the risk of being in a study such as being on dialysis, having liver cirrhosis, or active cancer will not be enrolled. Also, patients who really have to be on a beta-blocker (such as those who recently had a heart attack) cannot participate as it would be unethical for them to potentially
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Apr 04, 2016
- Source ID
- W81XWH1510705
Entities
People
- Mark T Dransfield
Organizations
- United States Army
- University of Alabama at Birmingham