EMBRACE (azithromycin)
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
30.0% male
N = 141
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
0.59 /pt
1.57 /pt
1.6/pt
1.2/pt
0.8/pt
0.4/pt
0.0/pt
Azithromycin
Placebo
Significant
decrease ▼
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 FEV1 (0 L vs. -0.04 L; AD 0.04 L, 95% CI -0.03 to 0.12).
No significant difference in St. George's Respiratory Questionnaire total score (-5.17 points vs. -1.92 points; AD -3.25 points, 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
Wong C, Jayaram L, Karalus N et al. Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial. Lancet. 2012 Aug 18;380(9842):660-7.
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