The findings are reported in this week’s New England Journal of Medicine.
Even patients who are treated with standard bronchodilator and steroid inhalers to control COPD symptoms commonly have one or more flare ups of the disease each year, which means more doctor and hospital visits, lost work days and reduced lung function, explained Frank Sciurba, M.D., associate professor of medicine, Pitt School of Medicine, and leader of the local arm of the study.
“Several small studies suggested that antibiotics called macrolides can have immune-modulating and anti-inflammatory effects that led to fewer exacerbations of COPD,” he said. “Our large trial shows it is true, and provides a way to improve the quality of life for patients whose breathing has been terribly impaired by this progressive and deadly disease.”
For the study, which was conducted by the COPD Clinical Research Network and led by Richard K. Albert, M.D., of the University of Colorado Denver Health Sciences Center, more than 1,100 COPD patients from 17 sites in 12 academic centers participated in the trial. About half of them were randomly assigned to take the macrolide antibiotic azithromycin every day for a year, while the rest took a placebo daily for the same time period. The Pitt arm enrolled 91 participants.
The median time to first COPD exacerbation was 266 days in the azithromycin group and 174 days in the placebo group. Also, exacerbations occurred 27 percent less frequently in the azithromycin group. There was a slightly greater likelihood of hearing problems in the azithromycin group, which is a known risk of prolonged use of the antibiotic, and the presence of antibiotic-resistant organisms was detected in some patients, although the infection rate was not higher.
“Acute exacerbations account for a significant part of COPD’s health burden,” said Susan B. Shurin, M.D., acting director of the National Heart, Lung and Blood Institute (NHLBI), part of the National Institutes of Health, which funded the trial. “These promising results with azithromycin may help us reduce that burden and improve the lives of patients at risk.”
More research needs to be done to assess the safety of using azithromycin in COPD patients for longer than a year, and it’s not clear what impact that might have on antibiotic resistance, said trial co-investigator John Reilly, M.D., professor of medicine, Pitt School of Medicine.
According to NHLBI, COPD affects over 12 million people in the United States and is now the third leading cause of death in the United States. There currently is no cure, though a combination of drugs and lifestyle changes can help manage the symptoms.
“This work is representative of several very important contributions to understanding and treating this very difficult disease made by the Emphysema/COPD Research Center,” said Mark Gladwin, M.D., chief, Division of Pulmonary, Allergy and Critical Care Medicine, Pitt School of Medicine.
For more information about ongoing projects at the Emphysema/COPD Research Center, call 866 948-2673 (COPD).