Abstract
Background: RESPIRE 1 assessed the efficacy and safety of Ciprofloxacin DPI in adult NCFB patients in a prospective, randomised, double-blind, multicentre, placebo-controlled trial.Methods: NCFB patients with ³2 exacerbations in prior 12 months and positive predefined bacterial culture in sputum (including P. aeruginosa) 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 vs pooled placebo (for FDA) and frequency of exacerbation vs matched placebo (for EMA); a stringent exacerbation definition was used.*Results: Overall 416 patients were randomised. Primary endpoints: Ciprofloxacin DPI 14 day on/off regimen significantly prolonged time to first exacerbation vs pooled placebo (p=0.0005) and significantly reduced frequency of exacerbation vs matched placebo (p=0.0061) (Table). The 28 day on/off regimen had no significant effect for either endpoint. The frequency of treatment emergent adverse events was similar across groups.



Conclusion: Ciprofloxacin DPI 14 day on/off regimen for 48 weeks significantly prolonged time to first exacerbation, reduced exacerbation frequency in NCFB patients and was well tolerated.