SESSION TITLE: Late-Breaking Abstracts
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Tuesday, October 25, 2016 at 08:45 AM - 10:00 AM
PURPOSE: RESPIRE 1 and 2 will evaluate the efficacy and tolerability of Ciprofloxacin DPI as long-term intermittent therapy to reduce exacerbations in a well-defined bronchiectasis cohort.
METHODS: Patients with ≥2 exacerbations in the prior 12 months and positive bacterial sputum culture for predefined bacteria (incl. P. aeruginosa) were randomized 2:1 to Ciprofloxacin DPI 32.5mg or placebo administered BID using a pocket-sized inhaler as a cyclical regimen of either 14 days on/off drug or 28 days on/off drug for 48 weeks. Primary endpoints were time to 1st exacerbation (FDA) and frequency of exacerbation (EMA) with exacerbation defined as presence of 3 criteria: systemic antibiotic treatment; worsening of ≥3 signs and symptoms (dyspnea, wheezing, cough, 24-hour sputum volume, or sputum purulence) for ≥48h; and fever (>38.0°C) or malaise/fatigue. Adverse events (AEs) were also evaluated.