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Late-Breaking Abstracts |

Efficacy and Tolerability of Ciprofloxacin Dry Powder for Inhalation (Ciprofloxacin DPI) in Bronchiectasis (Non-CF Etiology): Results From the Phase III RESPIRE 1 Study

Anthony De Soyza, MD; Timothy Aksamit, MD; Tiemo-Joerg Bandel, MD; Margarita Criollo, MD; J. Stuart Elborn, MD; Ulrike Krahn, PhD; Maxine Lau, PhD; Elisabeth Operschall, PhD; Eva Polverino, MD; Kevin Winthrop, MD; Robert Wilson, MD
Author and Funding Information

Newcastle University and Freeman Hospital, Newcastle Upon Tyne, United Kingdom


Copyright 2016, American College of Chest Physicians. All Rights Reserved.


Chest. 2016;150(4_S):1315A. doi:10.1016/j.chest.2016.08.1446
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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.

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