부산대학교 도서관

Job van der Palen,1,2 Wendy Moeskops-van Beurden,1 Carolyn M Dawson,3 Wai-Yee James,3 Andrew Preece,4 Dawn Midwinter,4 Neil Barnes,5 Raj Sharma6 1Department of Pulmonology, Medisch Spectrum Twente, Enschede, the Netherlands; 2Department of Research Methodology, Measurement, and Data Analysis, University of Twente, Enschede, the Netherlands; 3William Harvey Heart Centre, St Bartholomew Hospital, London, UK; 4Respiratory Therapy Area Unit, GlaxoSmithKline, Stockley Park, UK; 5Medical Department, GlaxoSmithKline, Brentford, UK; 6Respiratory Medical Franchise, GlaxoSmithKline, Brentford, UK Background: Administering maintenance COPD therapy with a combination of multiple inhalers may increase inhaler errors. This study evaluated the potential benefits of using a single Ellipta dry powder inhaler (DPI) compared with two combinations of DPIs commonly used to deliver triple maintenance therapy.Methods: Patients receiving inhaled COPD medication were enrolled in this multicenter, randomized, open-label, placebo-device, crossover study with a 2×2 complete block design (NCT0298218), which comprised two substudies: Ellipta vs Diskus + HandiHaler (substudy 1) or Turbuhaler + HandiHaler (substudy 2). Patients demonstrated inhaler use after reading the relevant patient information leaflet (PIL). A trained investigator assessed user errors (critical errors [errors likely to result in no or significantly reduced medication being inhaled] and overall errors). The primary endpoint was the proportion of patients making ≥1 critical error after reading the PIL. The secondary endpoints included error rates during ≤2 reassessments following investigator instruction (if required), instruction time, and patient preference.Results: After reading the PIL, significantly fewer patients made critical errors with Ellipta compared with Diskus + HandiHaler (9% [7/80] vs 75% [60/80], respectively; P