RT Journal Article
SR Electronic
T1 Efficacy and safety of ciprofloxacin dry powder for inhalation in patients with non-cystic fibrosis bronchiectasis
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP 1929
VO 38
IS Suppl 55
A1 Robert Wilson
A1 Tobias Welte
A1 Eva Polverino
A1 Anthony De Soyza
A1 Hugh W. Greville
A1 Anne E. O'Donnell
A1 Jeff Alder
A1 Peter Reimnitz
A1 Barbara Hampel
YR 2011
UL http://erj.ersjournals.com/content/38/Suppl_55/1929.abstract
AB 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.