Ciprofloxacin dry powder for inhalation in non-cystic fibrosis bronchiectasis: a
phase II randomised study.
Author(s): Wilson R(1), Welte T, Polverino E, De Soyza A, Greville H, O'Donnell A, Alder J,
Reimnitz P, Hampel B.
Affiliation(s): Author information:
(1)Host Defence Unit, Royal Brompton Hospital, London, UK. r.wilson@rbht.nhs.uk
Publication date & source: 2013, Eur Respir J. , 41(5):1107-15
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.
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