LATE-BREAKING ABSTRACT: Baseline demographic profile of subjects of the phase 3 RESPIRE 1 trial of ciprofloxacin dry powder for inhalation (DPI) in non-cystic fibrosis bronchiectasis (NCFB)

Abstract

Background: Ciprofloxacin DPI is in development to reduce the frequency of acute exacerbations in NCFB patients. The RESPIRE 1 trial is designed to assess the efficacy and safety of Ciprofloxacin DPI as long-term, intermittent, inhaled antibacterial therapy in patients with idiopathic or post-infectious NCFB. RESPIRE 1 is a placebo-controlled phase 3 trial in NCFB patients with ≥2 exacerbations in the previous 12 months and positive sputum culture for one of 7 pre-defined bacteria, including but not limited to Pseudomonas aeruginosa . The trial has completed enrollment. Methods: We evaluated preliminary demographic and disease characteristics of subjects randomised in RESPIRE 1. Results: A total of 902 patients were screened and 416 (46.1%) were randomised. The majority of randomised patients were female with idiopathic NCFB and positive P. aeruginosa cultures (Figure). Marked impairment of health-related quality of life was reported (mean SGRQ). Conclusions: Baseline characteristics of subjects randomised in RESPIRE 1 represent a frequently exacerbating NCFB population. The study population appears to be well-suited to evaluating the impact of inhaled antibacterial therapy on the frequency of acute exacerbations in patients with NCFB. ![Figure][1] [1]: pending:yes