Respiratory Trials·org

Bronchiectasis · Long-term macrolides

EMBRACE randomised trial

Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis

EMBRACE trial design and results
Design Randomised, double-blind, placebo-controlled trial
Treatment Azithromycin 500 mg three times per week
Control Placebo
Population 141 patients with non-cystic fibrosis bronchiectasis and at least one exacerbation in the past year
Follow-up 6 months of treatment with follow-up to 12 months
Primary endpoint Rate of event-based exacerbations
Result Event-based exacerbations occurred at 0.59 per patient with azithromycin versus 1.57 with placebo over the 6-month treatment period — rate ratio 0.38 (95% CI 0.26 to 0.54, p<0.0001). Prebronchodilator FEV1 did not differ significantly, nor did St George's Respiratory Questionnaire score.
Secondary endpoints FEV1, St George's Respiratory Questionnaire, adverse events, macrolide resistance

Azithromycin is a new option for prevention of exacerbations in patients with non-cystic fibrosis bronchiectasis with a history of at least one exacerbation in the past year.

The trial authors, in the published abstract

How it has aged

One of three concordant macrolide trials in bronchiectasis with BAT and BLESS, and the effect size here is the largest. That neither lung function nor quality of life improved is worth saying out loud: this prevents attacks rather than making patients feel better day to day.

Publications

Azithromycin for prevention of exacerbations in non-cystic fibrosis bronchiectasis (EMBRACE): a randomised, double-blind, placebo-controlled trial

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.

  • Exacerbation rate 0.59 versus 1.57 per patient over 6 months
  • No significant change in FEV1 or quality of life score