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. (December 2022)

• Record Type: Journal Article
• Authors: van der Palen, Job; Slade, David; Rehal, Sunita; Verma, Manish; Plank, Maximilian
• Is Part Of: Respiratory medicine. Volume 205(2022)
• Publication Date: 2022-12
• Subjects: Asthma -- ELLIPTA -- BREEZHALER -- Dry powder inhaler -- Error rate -- Inhaler technique -- Patient preference; CI confidence interval -- COPD chronic obstructive pulmonary disease -- DPI dry powder inhalers -- GINA Global Initiative for Asthma -- HCP healthcare professional -- ICS inhaled corticosteroids -- IQR interquartile range -- LABA long-acting β2-agonist -- LAMA long-acting muscarinic antagonist -- OR odds ratio -- PIL patient information leaflet -- SABA short-acting β2-agonist -- SD standard deviation; Chest -- Diseases -- Periodicals; Chest -- Diseases -- Great Britain -- Periodicals; Respiratory organs -- Diseases -- Periodicals; Respiratory Tract Diseases -- Periodicals; Appareil respiratoire -- Maladies -- Périodiques; Thorax -- Maladies -- Périodiques; Appareil respiratoire -- Maladies -- Traitement -- Périodiques; Electronic journals; 616.2
• DOI: 10.1016/j.rmed.2022.107031
• Languages: English
• ISSNs: 0954-6111

Abstract

Abstract: 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. Highlights: We assessed errors by asthma patients using placebo ELLIPTA or BREEZHALER inhalers. Our crossover study included adults naive to the tested inhalers. Inhaler use was assessed after patients read the patient information leaflet (PIL). Fewer patients made ≥1 overall/critical error with ELLIPTA vs BREEZHALER post PIL. Fewer patients required further instruction post PIL with ELLIPTA vs BREEZEHALER.