University of Michigan and VA were one of 10 centers nationwide to participate in research trial
Adding a common antibiotic to the usual treatment regimen for chronic obstructive pulmonary disease (COPD) can reduce acute exacerbations –sudden onsets of worsened cough, wheeze, and labored breathing – and improve quality of life, reports a new clinical trial funded by the National Heart, Lung, and Blood Institute (NHLBI), part of the National Institutes of Health.
The University of Michigan Health System and Veterans Administration Ann Arbor Healthcare System, under the direction of lung specialists Fernando Martinez, M.D., M.S., and Jeffrey Curtis, M.D., were one of 10 centers involved in the large-scale clinical trial. Martinez and his colleagues in U-M’s Division of Pulmonary and Critical Care Medicine provided key preliminary data supporting antibiotic treatment and were involved in the trial’s design.
Findings will appear in the August 25 New England Journal of Medicine.
“Exacerbations account for a significant part of COPD’s health burden,” said Susan Shurin, M.D., acting director of the NHLBI. “These promising results with azithromycin may help us reduce that burden and improve the lives of patients at risk of these acute attacks.”
Previous research had suggested that the antibiotic azithromycin might be effective in reducing COPD exacerbations, which are typically caused by bacteria, viruses or a combination of both. Azithromycin is already prescribed for a wide variety of bacterial infections including pneumonia and strep throat. This study was the first to enroll a large number of patients and treat them for a long time.
The 570 study participants who took 250 mg of azithromycin daily for a year in addition to their usual care averaged 1.48 acute COPD exacerbations annually, compared to 1.83 exacerbations for the 572 participants who received their usual care without azithromycin. The participants taking azithromycin also responded more favorably on questionnaires that asked them to assess their breathing ability and overall well-being.
Eighty percent of the study participants were already taking other medications normally used to manage COPD, like inhaled steroids and long-acting bronchodilators. This suggests that azithromycin adds benefits to other therapies.
Side effects of this commonly prescribed antibiotic were minimal. Azithomycin increased the presence of antibiotic-resistant microbes in some patients, although no one developed an infection. It also caused slight hearing decrements in a small fraction of participants.
Dr. James Kiley, director of the NHLBI’s Division of Lung Diseases, added that more research is needed to determine the long-term effects of azithromycin treatment and to identify which group of patients would benefit the most. Patients in this study were selected based on a history of exacerbations in the previous year or a need for oxygen therapy.
“At this point it’s too soon to extend these findings to every patient with COPD,” Kiley said.
COPD is a progressive disease of the lungs that affects over 12 million people in the United States and is now the third leading cause of death in this country. There is currently no cure, though a combination of drugs and lifestyle changes can help manage the symptoms and slow disease progression.
“This important research is just one of many efforts – both at U-M and around the country – aimed at helping patients with COPD breathe easier and enjoy a better quality of life,” Martinez says.
Beyond this study, U-M investigators have been actively involved in helping to understand, diagnose and develop new treatments for COPD.
For example, MeiLan K. Han, M.D., M.S., assistant professor of internal medicine at the U-M Medical School, was the lead author of a recent study which used CT scans (computed tomography) to identify structural changes in the lungs of patients with COPD associated with frequent exacerbations. These insights lay the groundwork for possible new therapeutic approaches.
Earlier this year, John R. Erb-Downward, Ph.D., and Deborah L. Thompson, Ph.D., of U-M were the lead researchers on a study analyzing the potential role lung bacteria play in the development of COPD, especially in smokers. These investigators, in collaboration with Curtis, U-M and VA, demonstrated that there are significant differences in bacterial communities even within the lungs of a single patient with advanced COPD. The research is helping scientists understand how COPD first develops in patients and may pave the way for new types of treatments. Gary B. Huffnagle, Ph.D., professor of microbiology and immunology, and Martinez, also a professor of internal medicine at the U-M Medical School, were co-senior authors of the paper.
Meanwhile, U-M investigators, led by Martinez, have been involved in leadership roles in many of the recent major COPD initiatives funded by the National Institutes of Health, including the National Emphysema Treatment Trial (NETT), COPD Clinical Research Network (CCRN), Long Term Oxygen Treatment Trial (LOTT), COPDGene, Lung Tissue Research Consortium (LTRC), and Subpopulations and Intermediate Outcome Measures in COPD Study (SPIROMICS).
Several of these initiatives are actively recruiting at U-M. The university also has a continuing need for volunteers in other breathing disorder research. For more information visit: www.UMClinicalStudies.org.
The new study was carried out by the CCRN, an NHLBI-funded consortium of research centers located throughout the U.S. that was established to identify new treatments for COPD.
U-M investigators involved in the study included Martinez, Han, and Curtis, along with Kevin Flaherty, M.D., M.S., Steven Gay, M.D., M.S., Thomas Sisson, M.D., and Theodore Standiford, M.D., all lung specialists in the Department of Internal Medicine.
Learn more about the study: Macrolide Azithromycin to Prevent Rapid Worsening of Symptoms Associated with COPD (NCT00325897) at http://clinicaltrials.gov/ct2/show/NCT00325897
Disclosure: U-M’s Flaherty, Gay, Han, and Martinez serve as consultants or on the speakers bureau for Pfizer, a maker of azithromycin.
The National Heart, Lung, and Blood Institute (NHLBI) is a component of the National Institutes of Health. NHLBI plans, conducts, and supports research related to the causes, prevention, diagnosis, and treatment of heart, blood vessel, lung, and blood diseases; and sleep disorders. The Institute also administers national health education campaigns on women and heart disease, healthy weight for children, and other topics. NHLBI press releases and other materials are available online at: www.nhlbi.nih.gov.
To schedule an interview with an NHLBI spokesperson, contact the NHLBI Office of Communications at 301-496-4236 or www.nih.gov.
(U-M release adapted from NHLBI release.)