| Design | Double-blind, placebo-controlled RCT |
|---|---|
| Treatment | Azithromycin 250 mg daily for one year, added to usual care |
| Control | Placebo |
| Population | 1142 patients with COPD at increased risk of exacerbation |
| Follow-up | 1 year |
| Primary endpoint | Time to first acute exacerbation of COPD |
| Result | Median time to first exacerbation 266 days (95% CI 227 to 313) with azithromycin versus 174 days (143 to 215) with placebo, p<0.001; HR 0.73 (0.63 to 0.84). Exacerbation frequency 1.48 versus 1.83 per patient-year (p=0.01). SGRQ improved by 2.8 versus 0.6 points (p=0.004). Hearing decrements occurred in a small proportion of patients. |
| Secondary endpoints | Exacerbation frequency, quality of life, hearing, microbial resistance |
Among selected subjects with COPD, azithromycin taken daily for 1 year, when added to usual treatment, decreased the frequency of exacerbations and improved quality of life but caused hearing decrements in a small percentage of subjects.
The trial authors, in the published abstract
Still the basis for long-term macrolide prophylaxis in frequent exacerbators, and still constrained by the same two unresolved harms the trial itself flagged: ototoxicity and antimicrobial resistance. Patients with prolonged QT interval or hearing loss were excluded, and that exclusion carried into practice.
Albert RK, Connett J, Bailey WC, et al. Azithromycin for prevention of exacerbations of COPD. N Engl J Med 2011 Aug 25;365(8):689-98.