BLESS
Trial question
What is the role of low-dose erythromycin in patients with non-cystic fibrosis bronchiectasis?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
61.0% female
39.0% male
N = 117
117 patients (71 female, 46 male).
Inclusion criteria: patients with non-cystic fibrosis bronchiectasis with a history of ≥ 2 infective exacerbations in the preceding year.
Key exclusion criteria: CF, current mycobacterial disease or bronchopulmonary aspergillosis, reversible cause for exacerbations, maintenance oral antibiotic prophylaxis, prior macrolide use except short-term, or cigarette smoking within 6 months.
Interventions
N=59 erythromycin (BID erythromycin ethylsuccinate 400 mg for 48 weeks, followed by a 4-weeks washout period).
N=58 placebo (matching placebo BID).
Primary outcome
Pulmonary exacerbations
1.29 / p-y
1.97 / p-y
2.0/ p-y
1.5/ p-y
1.0/ p-y
0.5/ p-y
0.0/ p-y
Erythromycin
Placebo
Significant
decrease ▼
Significant decrease in pulmonary exacerbations (1.29/ p-y vs. 1.97/ p-y; IRR 0.57, 95% CI 0.42 to 0.77).
Secondary outcomes
Significant increase in 24-hour sputum production (-5.4 vs. -1.7).
Significant increase in lung function decline
(predicted) (4.6% vs. 6.6%).
Significant increase in macrolide-resistant oropharyngeal streptococci (27.7% vs. 0.04%; AD 25.5%, 95% CI 10.37 to 40.63).
Safety outcomes
Significant difference in adverse events (28.8% vs. 25.9%).
Conclusion
In patients with non-cystic fibrosis bronchiectasis with a history of ≥ 2 infective exacerbations in the preceding year, erythromycin was superior to placebo with respect to pulmonary exacerbations.
Reference
Serisier DJ, Martin ML, McGuckin MA et al. Effect of long-term, low-dose erythromycin on pulmonary exacerbations among patients with non-cystic fibrosis bronchiectasis: the BLESS randomized controlled trial. JAMA. 2013 Mar 27;309(12):1260-7.
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