Inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis and chronic lung infection with Pseudomonas aeruginosa (ORBIT-3 and ORBIT-4): Two phase 3, randomised controlled trials
The Lancet Respiratory Medicine Mar 04, 2019
Haworth CS, et al. - In two international, randomised, double-blind, placebo-controlled, phase 3 trials, the ORBIT-3 and ORBIT-4, researchers assessed the safety and efficacy of inhaled liposomal ciprofloxacin (ARD-3150) in patients who had non-cystic fibrosis bronchiectasis, had had at least two pulmonary exacerbations treated with antibiotics in the previous 12 months, and had a history of chronic P aeruginosa lung infection. Either ARD-3150 or placebo was randomly (2:1) administered to patients. For six 56-day treatment cycles, ARD-3150 (3 mL liposome encapsulated ciprofloxacin 135 mg and 3 mL free ciprofloxacin 54 mg) or 6 mL placebo (3 mL dilute empty liposomes mixed with 3 mL of saline) was self-administered once daily, for 48 weeks. Remarkably longer median time to first pulmonary exacerbation was observed in association with ARD-3150 vs placebo, in ORBIT-4, but not in ORBIT-3 or the pooled analysis, among patients with non-cystic fibrosis bronchiectasis and chronic P aeruginosa lung infection requiring antibiotic therapy in the preceding year. Inconsistency was noted between the trials.
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