A new dawn: inhaled antibiotics for patients with bronchiectasis

Abstract

The absence of licensed medications for non-cystic fibrosis bronchiectasis is concerning in the context of the high and increasing burden of bronchiectasis in adults 1 and children. 2 In The Lancet Respiratory Medicine , Charles Haworth and colleagues 3 report promising data from two double-blind randomised controlled trials (ORBIT-3 and ORBIT-4) examining the efficacy of a once-daily inhaled antibiotic composed of liposome-encapsulated ciprofloxacin and free ciprofloxacin (ARD-3150), which is a welcome advancement in the bronchiectasis field in which few such trials exist. 4 In ORBIT-3 and ORBIT-4, 3 Haworth and colleagues enrolled 278 (ORBIT-3) and 304 (ORBIT-4) patients with non-cystic fibrosis bronchiectasis who were chronically infected with Pseudomonas aeruginosa . Patients were randomly assigned (2:1) to receive either ARD-3150 or placebo, which was self-administered once daily for six 56-day treatment cycles, for 48 weeks. 3 The primary endpoint was time to the first pulmonary exacerbation from the date of randomisation to week 48. Treatment with ARD-3150 resulted in a significant prolongation of median time to first pulmonary exacerbation in ORBIT-4 of 230 days compared with 158 days in the placebo group, a difference of 72 days (hazard ratio 0·72 [95% CI 0·53–0·97], p=0·032), but no significant prolongation was observed in ORBIT-3 or a pooled analysis of both trials. Secondary and post-hoc analyses of pooled data revealed significant risk reductions in exacerbation frequency and severity in those receiving ARD-3150, and significant reductions in sputum P aeroginosa density during active treatment cycles, but no between-group changes in quality of life or lung function. 3