This safety and efficacy study follows the successful completion of a Phase I safety, tolerability and pharmacokinetics trial in healthy volunteers and the previously executed preclinical toxicology program.
The Phase II study is a multicenter trial in 24 adult cystic fibrosis patients. Following an antibiotic washout period, patients will receive inhaled liposomal ciprofloxacin for a period of 14 consecutive days.
Primary efficacy will be based on the change in the density of Pseudomonas Aeruginosa bacterial colony forming units in sputum between pre-dosing and post-dosing levels. Additional efficacy endpoints will include pulmonary function measurements and respiratory symptoms. The study is being conducted in leading cystic fibrosis centers in Australia and New Zealand.
The recently completed Phase I study was a dose-escalation trial of three dose levels of inhaled liposomal ciprofloxacin involving a total of 20 healthy adult volunteers. The study showed that the drug was well tolerated and no serious adverse events were reported.