A randomized, cross-over study comparing critical and overall errors, learning time, and preference of the ELLIPTA versus BREEZHALER dry powder inhalers in patients with asthma.

BACKGROUND: Many patients with asthma make errors using inhalers, affecting the amount of medication received. Previous evidence demonstrated that patients with asthma or chronic obstructive pulmonary disease make fewer critical errors with the ELLIPTA inhaler after reading the patient information leaflet (PIL) versus other dry powder inhalers. We assessed errors made by patients with asthma using placebo ELLIPTA or BREEZHALER inhalers. METHODS: This randomized, multicenter, open-label placebo inhaler-handling study (ClinicalTrials.gov: NCT04813354) with 2x2 complete block crossover design was conducted at three centers in the Netherlands and enrolled patients aged ≥18 years with mild-to-moderate asthma. Inclusion criteria were inhaler use for ≥12 weeks prior to enrollment and naivety to ELLIPTA and BREEZHALER inhalers. Patients were randomized to ELLIPTA or BREEZHALER inhaler first and were assessed for errors in use of both inhalers after 1) reading PIL instructions, 2) receiving further instruction from a healthcare professional (HCP) if they made an error. RESULTS: 114 patients with asthma (57% female; mean age of 55.3 years) were assessed. After reading the PIL, 6% of patients made ≥1 critical error with ELLIPTA versus 26% with BREEZHALER (odds ratio [OR]: 0.11 [95% confidence interval (CI): 0.01-0.40]; p < 0.001). With ELLIPTA, 27% of patients made ≥1 overall error after reading the PIL versus 41% with BREEZHALER (OR: 0.25 [95% CI: 0.03-0.74]; p = 0.005). Fewer patients required HCP instruction with ELLIPTA than BREEZHALER (25% versus 32%). CONCLUSIONS: Fewer patients made critical and overall errors using the ELLIPTA inhaler versus BREEZHALER after reading the PIL.