Abstract

Introduction: Potentially pathogenic microorganisms (PPMs) frequently colonize lungs of bronchiectatic patients, often leading to pulmonary exacerbations. This phase II, randomized, double-blind study assessed the safety and efficacy of ciprofloxacin dry powder for inhalation (DPI) – a formulation (PulmoSphere™) using the T-326 inhaler – over 28 days in patients with sputum culture positive for predefined PPMs.

Objective: To test the effect of ciprofloxacin DPI on bacterial load and health status in non-cystic fibrosis bronchiectasis (non-CF BE) patients.

Methods: 124 adult, non-CF BE patients (mean baseline characteristics: age 63, 34% male, FEV1 56% of predicted) received 32.5mg ciprofloxacin (50 mg ciprofloxacin DPI) or matching placebo twice daily for 28 days with a 56-day follow-up. In addition to the primary endpoint (reduction in total bacterial load in sputum at end of treatment [EOT]), patient-reported health status was assessed with the St George's Respiratory Questionnaire (SGRQ).

Results: Ciprofloxacin DPI reduced bacterial load at EOT (–3.6 vs –0.3 logs, p<0.001). The difference in mean SGRQ total score between active and placebo was –3.6 (p=0.059, 95% confidence interval –7.3 to 0.1), close to a clinically relevant (–4) improvement. The trend lasted for 4 weeks after EOT (difference –3.0) but was not maintained at 8 weeks after EOT (difference –0.83). SGRQ domain scores, responder and per-protocol analyses confirmed the trend.

Conclusions: Ciprofloxacin DPI clearly trended towards improving patient-reported health status in non-CF BE measured with the SGRQ, which lasted for 4 weeks after treatment finished. Further study is required to confirm the results.