Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.

ABSTRACT: Treatment of infective bronchitis involving Pseudomonas aeruginosa is a cornerstone of care in patients with cystic fibrosis (CF). This phase IIb, randomised, double-blind, placebo-controlled study assessed the efficacy and safety of ciprofloxacin dry powder for inhalation (DPI) in this population.Patients with CF, ?12?years of age (N=286), were randomised to ciprofloxacin DPI (32.5?mg (n=93) or 48.75?mg (n=93)), or corresponding placebo (32.5?mg, n=65; 48.75?mg, n=35) twice daily for 28?days. The primary objective was the change in forced expiratory volume in 1?s (FEV1) from baseline (day 0) to end of treatment (day 29) in the intent-to-treat population for ciprofloxacin DPI compared with the corresponding placebo group.The primary effectiveness objective was not met; there were no significant differences in change in FEV1 between ciprofloxacin DPI and the corresponding placebo group for either dose (p=0.154). However, in pooled analyses, FEV1 decline from baseline to treatment end was significantly lower with ciprofloxacin DPI than with placebo (pooled data; p=0.02). Ciprofloxacin DPI showed positive effects on sputum bacterial load and quality of life, but these effects were not maintained at the 4-week follow-up. Ciprofloxacin DPI was well tolerated and there were no significant differences in type/incidence of treatment-emergent adverse events by treatment group (p=0.115).Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF.Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.

SUBMITTER: Dorkin HL 

PROVIDER: S-EPMC4680008 | biostudies-literature | 2015

REPOSITORIES: biostudies-literature