Patients’ ability to use a novel fluticasone propionate/formoterol breath-triggered inhaler (BTI) vs. budesonide/formoterol dry powder inhaler (DPI)

Introduction: GINA guidelines recognise the importance of correct inhaler technique and patient preference when individualising therapy. A novel BTI (Flutiform® K‑haler®) has been developed to deliver fluticasone propionate/formoterol (FP/FORM). Aims and Objectives: To investigate correct inhaler handling of FP/FORM BTI vs. budesonide/formoterol (BUD/FORM) DPI (Symbicort® Turbohaler®). The primary objective was to show superiority of FP/FORM BTI vs. BUD/FORM DPI as determined by the proportion of patients performing all critical steps correctly 12 weeks after initial training on Day 1. Methods: This was a multicentre, randomised, open-label study. 369 patients aged ≥18 years with persistent asthma, asthma-COPD overlap or COPD and naïve to both study devices were randomised. Patients received FP/FORM BTI or BUD/FORM DPI twice daily for 12 weeks then crossed over to the alternate treatment for 12 weeks. In each period, patients were trained and assessed on device handling by a HCP on Day 1 and handling technique was assessed at Week 12. Results: FP/FORM BTI was superior to BUD/FORM DPI for proportion of patients performing all critical steps correctly at Week 12 (94.0% vs. 82.4%; odds ratio: 2.89; 95% CI: 1.57, 5.33; p<0.001). A higher proportion of patients could perform all steps correctly (secondary endpoint) when using FP/FORM BTI compared to BUD/FORM DPI (73.7% vs. 61.6%; odds ratio: 1.85; 95% CI: 1.30, 2.62; p<0.001). Conclusions: The study met its primary objective and demonstrated superiority in correct inhaler handling of FP/FORM BTI versus BUD/FORM DPI 12 weeks after training. EudraCT: 2014-004564-38. Funded by Mundipharma Research Ltd.