title: Ciprofloxacin DPI: a randomised, placebo-controlled, phase IIb efficacy and safety study on cystic fibrosis.
abstract: BACKGROUND
  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.
  
  
  METHODS
  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.
  
  
  RESULTS
  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).
  
  
  CONCLUSIONS
  Further investigations are needed to determine the full scope of the beneficial effects of ciprofloxacin DPI for patients with CF.
  
  
  BACKGROUND
  Clinicaltrials.gov NCT00645788; EudraCT 2008-008314-40.
authors.affiliation: Department of Respiratory Diseases , Children's Hospital Boston , Boston, Massachusetts , USA.
authors.forename: Henry L
authors.initials: HL
authors.lastname: Dorkin
authors.affiliation: Charité Campus Virchow-Klinikum , Berlin , Germany.
authors.forename: Doris
authors.initials: D
authors.lastname: Staab
authors.affiliation: Bayer Pharma AG , Berlin , Germany.
authors.forename: Elisabeth
authors.initials: E
authors.lastname: Operschall
authors.affiliation: Bayer HealthCare , Whippany, New Jersey , USA.
authors.forename: Jeff
authors.initials: J
authors.lastname: Alder
authors.affiliation: Bayer Inc , Mississauga, Ontario , Canada.
authors.forename: Margarita
authors.initials: M
authors.lastname: Criollo
keywords: Cystic Fibrosis