6/28/23, 9:53 PM EMBRACE (azithromycin) Pathway Feedback Search Clinical Topics Home Studies EMBRACE (azithromycin) EMBRACE (azithromycin) Disease Bronchiectasis Trial question What is the role of azithromycin in adult patients with non-cystic fibrosis bronchiectasis? Study design Multi-center Double blinded RCT Population Characteristics of study participants 70.0% female N = 141 30.0% male 141 patients (98 female, 43 male) Inclusion criteria: adult patients with non-cystic fibrosis bronchiectasis with 1 pulmonary exacerbation requiring antibiotic treatment in the past year Key exclusion criteria: history of cystic fibrosis; hypogammaglobulinemia; allergic bronchopulmonary aspergillosis; a positive culture of non-tuberculous mycobacteria in the past 2 years or at screening; macrolide treatment for > 3 months in the past 6 months; or unstable arrhythmia Interventions N=71 azithromycin (500 mg thrice weekly for 6 months) N=70 placebo (matching placebo thrice weekly for 6 months) Primary outcome Event-based exacerbations 1.6/pt 1.57 https://web.pathway.md/studies/recB5CEae1n7F5GRe 1/2 6/28/23, 9:53 PM EMBRACE (azithromycin) Pathway 1.2/pt 0.8/pt 0.59 0.4/pt Significant decrease 0.0/pt Azithromycin Placebo Significant decrease in event-based exacerbations (0.59 per patient vs. 1.57 per patient; RR 0.38, 95% CI 0.26 to 0.54) Secondary outcomes No significant difference in prebronchodilator FEV in 1 second (AD 0.04 L, 95% CI -0.03 to 0.12) No significant difference in St. George's Respiratory Questionnaire total score (-5.17 units vs. -1.92 units; AD -3.25 units, 95% CI -7.21 to 0.72) No significant difference in 6-minute walk test distance (0.88 m vs. -9.63 m; AD 10.52 m, 95% CI -5.12 to 26.15) Safety outcomes No significant differences in adverse events, drug discontinuation due to gastrointestinal symptoms. Significant differences in severe adverse events (6% vs. 13%), gastrointestinal symptoms (27% vs. 13%). Conclusion In adult patients with non-cystic fibrosis bronchiectasis with 1 pulmonary exacerbation requiring antibiotic treatment in the past year, azithromycin was superior to placebo with respect to a event-based exacerbations. Reference Gladstone DJ, Spring M, Dorian P et al. Atrial fibrillation in patients with cryptogenic stroke. N Engl J Med. 2014 Jun 26;370(26):2467-77. Open reference URL https://web.pathway.md/studies/recB5CEae1n7F5GRe 2/2