Patients with Chronic Obstructive Pulmonary Disease (COPD) and tracheostomy are at high risk for
exacerbations and hospitalizations. Macrolide treatment has shown to reduce exacerbations in
moderate-to-severe COPD. To evaluate the safety and the efficacy of long-term azithromycin use in
outpatients with severe COPD and tracheostomy.
A multicenter, randomized, uncontrolled, pilot trial evaluating the safety and the efficacy of azithromycin
500 mg three day-a-week for 6 months (AZI) vs. standard of care (SC) in severe COPD
outpatients with tracheostomy. Patients were monitored for six months of treatment plus six months of
follow up. The primary outcome was the reduction in the number of exacerbations and hospitalizations.
A total of 22 patients was randomized (11 to SC and 11 to AZI). Patients in AZI had a significant lower
cumulative number of exacerbations after the first 3 months of treatment when compared to patients in
SC (p 1⁄4 0.001), as well as hospitalizations (p1⁄4 0.02). Kaplan–Meier survival curves for time to first
exacerbation showed a significant reduction in AZI of the rates of first exacerbation when compared to SC
(log rank test1⁄4 12.14, p < 0.001), as well as to first hospitalization (log-rank 1⁄4 4.09, p 1⁄4 0.04). Azithromycin
significantly improved the quality of life in comparison to SC. No serious adverse events in the
AZI group were reported.
Long-term azithromycin treatment seems to be safe and effective in severe COPD outpatients with
tracheostomy in reducing exacerbations, hospitalizations, as well as in improving quality of life.
