Patients with chronic obstructive pulmonary disease (COPD) who have had a tracheostomy are at increased risk of developing COPD complications and hospitalization. In a number of studies, treatment with macrolides has been shown to reduce the incidence of complications in moderate to severe forms of COPD.

The purpose of a multicenter randomized pilot study at the University of Milan (Italy) was to assess the safety and efficacy of long-term use of azithromycin in patients with severe COPD and tracheotomy. Azithromycin was prescribed at a dose of 500 mg 3 times a week for 6 months and was compared with standard practice in the management of patients with severe COPD and outpatient tracheostomy. Patients were followed for 6 months of treatment and another 6 months during the follow-up period. The main outcome evaluated was a decrease in the number of exacerbations and hospitalizations.

A total of 22 patients participated in the study (11 people were randomized to azithromycin treatment and 11 patients received standard treatment). Patients in the azithromycin group showed a significantly lower cumulative number of complications of COPD after the first three months of treatment compared to patients who received standard treatment (p = 0.001). There was also a statistically significant decrease in the number of hospitalizations for COPD exacerbations in the azithromycin group (p = 0.02).

The Kaplan-Mayer curves for the time before the start of the first exacerbation showed a statistically significant decrease in the incidence of the first exacerbation in the azithromycin group over a period of time compared to standard patient management. (log classification criterion 12.14, p less than 0.001), as well as a significant decrease in the azithromycin frequency group from the first hospitalization for a certain period of time (log classification criterion 4.09, p = 0.04 ). In the context of treatment with azithromycin, a significant improvement in the quality of life of patients was noted compared to standard management of patients on an outpatient basis. No serious adverse events were noted with azithromycin treatment.

Thus, the results of the study allow us to conclude that long-term treatment with azithromycin in patients with severe COPD and ambulatory tracheostomy is effective and safe and can reduce the incidence of COPD exacerbations. , the number of hospitalizations and improve the quality of life.