CFI (Ciprofloxacin for Inhalation) is being developed as a chronic intermittent therapeutic agent to manage cystic fibrosis (CF) and non-CF bronchiectasis (BE) patients colonized with Pseudomonas aeruginosa ( PA) . CFI is a once a day inhaled liposomal controlled release formulation to achieve adequate sustained concentration of ciprofloxacin in the lung while minimizing potential for local and systemic side effects. Following a successful study in non-CF BE with 2 doses (6 mL (300 mg ciprofloxacin) or 3 mL (150 mg ciprofloxacin) we completed a randomized, multicentre, double-blind, placebo-controlled trial (ORBIT 1), evaluating even lower inhaled doses of CFI (3mL (150 mg ciprofloxacin) or 2 mL (100 mg ciprofloxacin) in 96 patients non-CF BE subjects. Aside from evaluating the mean decreases against placebo in the PA colony forming units, changes in QoL, lung function and 6 min walk will be assessed. In the open label study in 36 patients with non-CF BE CFI was well tolerated and both doses demonstrated significant mean decreases against baseline in the PA colony forming units (CFUs) at 28-days of 3.5 log 10 (p<0.001) and 4.0 log 10 (p<0.001) units, respectively, in the per protocol (PP) population. High concentration of ciprofloxacin was found in the sputum. No bronchodilator treatment was needed before or during inhaled study dug treatment. Primary efficacy data from ORBIT 1 will be presented at the ERS. Supported by Aradigm Corporation.
Bilton et al. (Thu,) studied this question.