Antimicrobial efficacy of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis

Introduction: Ciprofloxacin dry powder for inhalation (DPI) is a formulation (PulmoSphere™ technology) in development for long-term therapy of non-cystic fibrosis bronchiectasis (non-CF BE). This phase II, randomized, double-blind study was designed to assess efficacy and safety over 28 days in non-CF BE patients with positive sputum culture for predefined respiratory pathogens (RPs). Methods: Adult patients with non-CF BE received 32.5 mg ciprofloxacin (50 mg ciprofloxacin DPI) or matching placebo bid for 28 days, with a 56-day follow-up. The primary endpoint was reduction in total bacterial load in sputum at end of treatment (EOT). In addition, eradication of RPs and reduction of individual species was documented. Results: The primary endpoint of significant reduction in bacterial load of RPs at EOT was achieved (log 10 –3.6 vs –0.3 for placebo, p Pseudomonas aeruginosa , Haemophilus influenzae , Moraxella catarrhalis and Streptococcus pneumoniae . The eradication rates for the baseline pathogens at EOT were 35% vs 8% for placebo. At EOT, eradication was achieved in all patients infected at baseline with M. Catarrhalis and in all but 1 patient infected with H. influenzae. Conclusions: Ciprofloxacin DPI achieved a significantly greater reduction in total bacterial burden than placebo. A promising trend in reduction and eradication of the major pathogenic species was also noted. Ciprofloxacin DPI has demonstrated promise for long-term inhalation therapy to reduce the major pathogenic species in non-CF BE, which could reduce the incidence of exacerbations.