Abstract
Introduction: ARD-3150 (ARD) is a once-daily 6 mL nebulized formulation of liposomal (135 mg) and free (54 mg) ciprofloxacin that was tested in two 48-week phase 3 trials (ORBIT-3 [NCT01515007]; ORBIT-4 [NCT02104245]) in NCFB patients with chronic P. aeruginosa infection over 6 cycles of 28 days on/off treatment. Patients (pts) completing the double-blind period (DBP) could enter a 28-day OLE with ARD treatment + 30-day follow-up.
Aims: To evaluate responses to ARD in those previously receiving ARD or placebo (PB) treatment.
Methods: All pts received ARD for 28 days. Pulmonary exacerbations (PE), microbiological outcomes, and adverse events (AE) were monitored.
Results: In ORBIT-4 and ORBIT-3, 92%-97% of DBP completers entered the OLE. During the OLE, 11.1% (ORBIT-4) and 12.3% (ORBIT-3) pts had a PE. During DBP, ARD pts had PE rates of 0.98 and 1.09 and PB pts had rates of 1.47 and 1.31 PE/pt, respectively. When OLE PE rates were normalized to the 48-wk duration of the DBP, ARD rates were 0.53 and 0.55 PEs/pt and PB pts rates were 1.14 and 1.11 PE/pt. Both ARD and PB pts in DBP had a decline in PE rate during OLE. Entering OLE, 54.3% and 50.4%of ARD, and 66.7% and 75.8% of PB pts of ORBIT-4 and ORBIT-3, respectively, had ciprofloxacin MIC <2 mcg/mL. Sputum P. aeruginosa density (mean±SD (log10) CFU/gram) decreased from OLE baseline by -1.51±2.34 in the ARD DBP group and -1.44±3.03 in the PB DBP group in ORBIT-4 and ‑2.01±2.65 in the ARD DBP group and -2.48±3.49 in the PB DBP group in ORBIT-3. The safety profile observed during the DBP remained favorable during OLE in both trials.
Conclusions: The efficacy and safety profile of ARD was maintained during the OLE.
Footnotes
Cite this article as: European Respiratory Journal 2018 52: Suppl. 62, PA357.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2018