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Rationale Azithromycin, a macrolide antibiotic with anti-inflammatory and immunomodulatory properties, improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. We evaluated the effects of azithromycin in patients with non-cystic fibrosis bronchiectasis. Methods In a randomised, double-blind trial, we randomly assigned 141 patients with bronchiectasis to receive azithromycin (500mg three times a week) or placebo for 6 months. Patients were followed for an additional 6 months. The co-primary end points were event-based exacerbation frequency, forced expiratory volume in 1 second (FEV1) and health-related quality of life (St George's Respiratory Questionnaire, SGRQ). Secondary end points included time to first exacerbation, symptom-based exacerbation frequency, 6-minute walk distance, C-reactive protein (CRP), sputum cell counts, and adverse events. Results The annual rate of event-based exacerbations for the 6-month treatment period was 0.59 in the azithromycin group (71 patients) and 1.57 in the placebo group (70 patients), corresponding to a 62% reduction in the rate of exacerbations with azithromycin (rate ratio, 0.38: 95% CI, 0.26 to 0.54; P<0.001). For the 12-month period, the annual rate of exacerbations was 1.58 in the azithromycin group and 2.73 in the placebo group (rate ratio, 0.58: 95% CI, 0.46 to 0.74; P<0.001). Azithromycin, as compared with placebo, also increased the time to the first event-based exacerbation in the first 6 months (104 days vs 21 days), with a 66% reduction in risk (hazard ratio, 0.34; 95% CI, 0.20 to 0.56; p<0.001) and the time to the first exacerbation in 12 months (239 days vs 85 days; hazard ratio, 0.44: 95% CI, 0.29 to 0.65; P < 0.001). Analysis of CRP level on a log scale at 6 months gave geometric means of 4.03 and 5.95, an azithromycin/placebo ratio of 0.677 (p < 0.01). Symptom-based exacerbation frequency, change in FEV1, SGRQ, 6-minute walk distance, and sputum neutrophils were not significa

Rationale Azithromycin, a macrolide antibiotic with anti-inflammatory and immunomodulatory properties, improves lung function and reduces pulmonary exacerbations in patients with cystic fibrosis. We evaluated the effects of azithromycin in patients with non-cystic fibrosis bronchiectasis. Methods In a randomised, double-blind trial, we randomly assigned 141 patients with bronchiectasis to receive azithromycin (500mg three times a week) or placebo for 6 months. Patients were followed for an additional 6 months. The co-primary end points were event-based exacerbation frequency, forced expiratory volume in 1 second (FEV1) and health-related quality of life (St George's Respiratory Questionnaire, SGRQ). Secondary end points included time to first exacerbation, symptom-based exacerbation frequency, 6-minute walk distance, C-reactive protein (CRP), sputum cell counts, and adverse events. Results The annual rate of event-based exacerbations for the 6-month treatment period was 0.59 in the azithromycin group (71 patients) and 1.57 in the placebo group (70 patients), corresponding to a 62% reduction in the rate of exacerbations with azithromycin (rate ratio, 0.38: 95% CI, 0.26 to 0.54; P<0.001). For the 12-month period, the annual rate of exacerbations was 1.58 in the azithromycin group and 2.73 in the placebo group (rate ratio, 0.58: 95% CI, 0.46 to 0.74; P<0.001). Azithromycin, as compared with placebo, also increased the time to the first event-based exacerbation in the first 6 months (104 days vs 21 days), with a 66% reduction in risk (hazard ratio, 0.34; 95% CI, 0.20 to 0.56; p<0.001) and the time to the first exacerbation in 12 months (239 days vs 85 days; hazard ratio, 0.44: 95% CI, 0.29 to 0.65; P < 0.001). Analysis of CRP level on a log scale at 6 months gave geometric means of 4.03 and 5.95, an azithromycin/placebo ratio of 0.677 (p < 0.01). Symptom-based exacerbation frequency, change in FEV1, SGRQ, 6-minute walk distance, and sputum neutrophils were not significa