TY - JOUR
T1 - A new dawn
T2 - inhaled antibiotics for patients with bronchiectasis
AU - Grimwood, Keith
AU - Chang, Anne B.
PY - 2019/3/1
Y1 - 2019/3/1
N2 - 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 and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues 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. In ORBIT-3 and ORBIT-4, 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. 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.
AB - 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 and children. In The Lancet Respiratory Medicine, Charles Haworth and colleagues 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. In ORBIT-3 and ORBIT-4, 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. 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.
UR - http://www.scopus.com/inward/record.url?scp=85061437464&partnerID=8YFLogxK
U2 - 10.1016/S2213-2600(18)30456-9
DO - 10.1016/S2213-2600(18)30456-9
M3 - Comment/debate
C2 - 30658915
AN - SCOPUS:85061437464
SN - 2213-2619
VL - 7
SP - 188
EP - 189
JO - The Lancet Respiratory Medicine
JF - The Lancet Respiratory Medicine
IS - 3
ER -