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 FREE TO VIEW

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.

RESULTS: 416 patients were randomized into RESPIRE 1. Both primary endpoints were met in the 14d on/off arm: Ciprofloxacin DPI significantly prolonged time to 1st exacerbation vs pooled placebo (>336d vs 186d; adjusted hazard ratio [HR] 0.53; 97.5%CI 0.36-0.80; p=0.0005) and significantly reduced exacerbation frequency vs matched placebo (mean incidence rate over 48 weeks 0.78 vs 1.42; adjusted incidence rate ratio [IRR] 0.61, 97.5%CI 0.40-0.91; p=0.0061). A non-significant trend in favor of Ciprofloxacin DPI was seen for both primary endpoints in the 28d on/off regimen (time to 1st exacerbation: HR 0.73; 97.5%CI 0.50-1.07; p=0.065; frequency of exacerbations: IRR 0.98, 97.5%CI 0.64-1.48; p=0.89). Treatment-emergent (TE) AEs, serious AE (SAEs), and AEs leading to discontinuation were similar across groups. TE-AE rates (n[%]) for Ciprofloxacin DPI 14d on/off, 28d on/off, and pooled placebo respectively were 112[82.4], 110[78.0], and 114[83.2]; TE-SAE rates were 23[16.9], 28[19.9], and 32[23.4]. Occurrence of TE bronchospasm, n[%], was low and similar across groups occurring in 7[5.1], 7[5.0], and 10[7.3] patients treated with Ciprofloxacin DPI 14d on/off, 28d on/off, and placebo respectively.

CONCLUSIONS: RESPIRE 1 tested 14- and 28-day on/off Ciprofloxacin DPI vs placebo for 48 weeks and is the first international study to show that a long-term inhaled antibiotic therapy can reduce bronchiectasis exacerbations.

CLINICAL IMPLICATIONS: Coupled with a favorable safety profile, our efficacy data suggest Ciprofloxacin DPI may offer an effective, well-tolerated, long-term treatment option in bronchiectasis.

DISCLOSURE: Anthony De Soyza: Consultant fee, speaker bureau, advisory committee, etc.: Bayer lectures and advisory boards, Grant monies (from industry related sources): Bayer education grant Timothy Aksamit: Other: Participated in clinical trials activity. All money to Mayo Clinic Tiemo-Joerg Bandel: Employee: Bayer Pharma AG Margarita Criollo: Employee: Bayer Inc J. Stuart Elborn: Consultant fee, speaker bureau, advisory committee, etc.: Bayer - consultancy fees. All payments to Queen's University Belfast Ulrike Krahn: Employee: Bayer Pharma AG Maxine Lau: Employee: Bayer AG Elisabeth Operschall: Employee: Bayer AG Eva Polverino: Consultant fee, speaker bureau, advisory committee, etc.: Bayer Kevin Winthrop: Consultant fee, speaker bureau, advisory committee, etc.: Bayer - consultancy fees Robert Wilson: Consultant fee, speaker bureau, advisory committee, etc.: Bayer - lectures and advisory boards

Ciprofloxacin DPI is currently in Phase 3 trials for bronchiectasis and has not yet been approved for use.




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