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Abstract

Introduction: Ciprofloxacin dry powder for inhalation (DPI) uses PulmoSphere™ technology to target the lungs of patients chronically colonized with bacterial pathogens.

Objective: This phase II study assessed the efficacy and safety of ciprofloxacin DPI treatment for 28 days in non-cystic fibrosis bronchiectasis (non-CF BE) patients.

Methods: Adult patients with pulmonary stable non-CF BE received twice-daily 32.5 mg ciprofloxacin (50 mg ciprofloxacin DPI) or matching placebo 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) compared with placebo.

Results: The mean baseline characteristics in the intent-to-treat population (N=124) were: age 63, weight 70 kg, FEV1 56% of predicted. At EOT, ciprofloxacin DPI reduced mean bacterial load by 3.6 logs, vs 0.3 logs with placebo (p<0.001), and median CRP level was 2.45 mg/l lower compared with placebo (not significant). Mean difference in the St George's Respiratory Questionnaire at EOT was 3.6 points between treatment arms (p=0.059). Fewer patients treated with ciprofloxacin DPI than with placebo experienced an exacerbation requiring antibiotic treatment (23% vs 28%, not significant). The adverse event rate was similar in both treatment arms. Very few bronchospasms occurred (n=6, 2 after EOT). They were equally distributed between both groups.

Conclusions: Ciprofloxacin DPI significantly reduced bacterial load in patients with non-CF BE (p<0.001) and was well tolerated. Several secondary endpoints showed a trend in favour of ciprofloxacin DPI. Ciprofloxacin DPI is a promising candidate for investigating benefits of long-term therapy in non-CF BE patients.