title: Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a phase II randomised study.
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 of follow-up). Bacterial density in sputum (primary end-point), pulmonary function tests, health-related quality of life and safety were monitored throughout the study. 60 subjects received ciprofloxacin DPI 32.5 mg and 64 received placebo. Subjects on ciprofloxacin DPI had a significant reduction (p<0.001) in total sputum bacterial load at the end of treatment (-3.62 log10 CFU·g(-1) (range -9.78-5.02 log10 CFU·g(-1))) compared with placebo (-0.27 log10 CFU·g(-1) (range -7.96-5.25 log10 CFU·g(-1))); the counts increased thereafter. In the ciprofloxacin DPI group, 14 (35%) out of 40 subjects reported pathogen eradication at end of treatment versus four (8%) out of 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.
authors.affiliation: Host Defence Unit, Royal Brompton Hospital, London, UK. r.wilson@rbht.nhs.uk
authors.forename: Robert
authors.initials: R
authors.lastname: Wilson
authors.forename: Tobias
authors.initials: T
authors.lastname: Welte
authors.forename: Eva
authors.initials: E
authors.lastname: Polverino
authors.forename: Anthony
authors.initials: A
authors.lastname: De Soyza
authors.forename: Hugh
authors.initials: H
authors.lastname: Greville
authors.forename: Anne
authors.initials: A
authors.lastname: O'Donnell
authors.forename: Jeff
authors.initials: J
authors.lastname: Alder
authors.forename: Peter
authors.initials: P
authors.lastname: Reimnitz
authors.forename: Barbara
authors.initials: B
authors.lastname: Hampel
mesh_terms: D000280:Administration, Inhalation; D000368:Aged; D000900:Anti-Bacterial Agents / Q000008:administration & dosage; D058491:Bacterial Load; D001987:Bronchiectasis / Q000188:drug therapy*; D002939:Ciprofloxacin / Q000008:administration & dosage*; D015169:Colony Count, Microbial; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D058995:Dry Powder Inhalers; D005260:Female; D006801:Humans; D007249:Inflammation; D008171:Lung Diseases / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D011208:Powders; D011550:Pseudomonas aeruginosa; D016896:Treatment Outcome
chemical_list: D000900:Anti-Bacterial Agents; D011208:Powders; D002939:Ciprofloxacin