Abstract
This phase II, randomised, double-blind, multicentre study (NCT00930982) investigated the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) in patients with non-cystic fibrosis bronchiectasis.
Adults who were culture positive for pre-defined potential respiratory pathogens (including Pseudomonas aeruginosa and Haemophilus influenzae) were randomised to ciprofloxacin DPI 32.5 ;mg or placebo administered twice daily for 28 days (with 56 days' follow-up). Bacterial density in sputum (primary endpoint), pulmonary function tests, health-related quality of life and safety were monitored throughout the study.
Sixty subjects received ciprofloxacin DPI 32.5 ;mg and 64 received placebo. Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in sputum total bacterial load at end of treatment (–3.62 log10 [colony-forming units; CFU]/g [range –9.78 to 5.02]) compared with placebo (–0.27 log10 CFU/g [range –7.96 to 5.25]); the counts increased thereafter. In the ciprofloxacin DPI group, 35% (14/40) of subjects reported pathogen eradication at end of treatment, versus 8% (4/49) in the placebo group (p=0.001). No abnormal safety results were reported and rates of bronchospasm were low.
Ciprofloxacin DPI 32.5 ;mg twice daily for 28 days was well tolerated and achieved significant reductions in total bacterial load compared with placebo in subjects with non-cystic fibrosis bronchiectasis.
- ERS
ERJ Open articles are open access and distributed under the terms of the (Creative Commons Attribution Licence 3.0)