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LATE-BREAKING ABSTRACT: RESPIRE 1: Ciprofloxacin DPI 32.5mg b.d. administered 14 day on/off or 28 day on/off<i>vs</i>placebo for 48 weeks in subjects with non-cystic fibrosis bronchiectasis (NCFB)
Author Affiliations
Freeman Hospital, University of Newcastle Australia, Newcastle University, Mayo Clinic in Florida, ...
Year2016
Citations5
Abstract
<b>Background</b>: RESPIRE 1 assessed the efficacy and safety of Ciprofloxacin DPI in adult NCFB patients in a prospective, randomised, double-blind, multicentre, placebo-controlled trial. <b>Methods</b>: NCFB patients with ≥2 exacerbations in prior 12 months and positive predefined bacterial culture in sputum (including <i>P. aeruginosa</i>) were randomised 2:1 to Ciprofloxacin DPI 32.5mg b.d. or matching placebo. Two regimens were studied: 14 days on/off or 28 days on/off for 48 weeks. Data were evaluated using two analysis plans. The primary endpoints were time to first exacerbation <i>vs</i> pooled placebo (for FDA) and frequency of exacerbation <i>vs</i> matched placebo (for EMA); a stringent exacerbation definition was used.* <b>Results</b>: Overall 416 patients were randomised. Primary endpoints: Ciprofloxacin DPI 14 day on/off regimen significantly prolonged time…
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