Baseline profiles of subjects randomised in RESPIRE 2 trial of ciprofloxacin dry powder for inhalation (DPI) in non-CF bronchiectasis (NCFB) by pathogen and prior exacerbation rate

Background: RESPIRE 2 will assess if Ciprofloxacin DPI delays and reduces exacerbations and improves quality of life (QoL) in NCFB patients with ≥2 exacerbations in prior 12 months and sputum pathogens. It is unknown whether the presence of P. aeruginosa or other pathogens as well as frequency of reported exacerbations discriminates specific demographic and disease characteristics. Methods: We performed 2 subgroup analyses of baseline demographic and disease characteristics of subjects randomised in RESPIRE 2. Subjects with either P. aeruginosa or other predefined pathogens* at screening and those with a history of 2 or ≥3 exacerbations were evaluated. Results: Data of 521 subjects were analysed; each of the subgroups are reported (FIGURE). Poorer lung function and QoL were observed in subjects with P. aeruginosa vs other predefined pathogens; QoL and lung function were similarly independent of prior exacerbation rate; those with ≥3 vs 2 exacerbations had more P. aeruginosa, less S. aureus , and similar rates of H. influenzae . Conclusions: Baseline characteristics of RESPIRE 2 subjects with P. aeruginosa vs other pathogens showed differences as described in other cohorts. Efficacy analyses should confirm the importance of treating all subgroups of NCFB patients with ≥2 annual exacerbations and sputum pathogens with Ciprofloxacin DPI.