title: A randomised open-label cross-over study of inhaler errors, preference and time to achieve correct inhaler use in patients with COPD or asthma: comparison of ELLIPTA with other inhaler devices.
abstract: Errors in the use of different inhalers were investigated in patients naive to the devices under investigation in a multicentre, single-visit, randomised, open-label, cross-over study. Patients with chronic obstructive pulmonary disease (COPD) or asthma were assigned to ELLIPTA vs DISKUS (Accuhaler), metered-dose inhaler (MDI) or Turbuhaler. Patients with COPD were also assigned to ELLIPTA vs Handihaler or Breezhaler. Patients demonstrated inhaler use after reading the patient information leaflet (PIL). A trained investigator assessed critical errors (i.e., those likely to result in the inhalation of significantly reduced, minimal or no medication). If the patient made errors, the investigator demonstrated the correct use of the inhaler, and the patient demonstrated inhaler use again. Fewer COPD patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS, 9/171 (5%) vs 75/171 (44%); MDI, 10/80 (13%) vs 48/80 (60%); Turbuhaler, 8/100 (8%) vs 44/100 (44%); Handihaler, 17/118 (14%) vs 57/118 (48%); Breezhaler, 13/98 (13%) vs 45/98 (46%; all P<0.001). Most patients (57-70%) made no errors using ELLIPTA and did not require investigator instruction. Instruction was required for DISKUS (65%), MDI (85%), Turbuhaler (71%), Handihaler (62%) and Breezhaler (56%). Fewer asthma patients made critical errors with ELLIPTA after reading the PIL vs: DISKUS (3/70 (4%) vs 9/70 (13%), P=0.221); MDI (2/32 (6%) vs 8/32 (25%), P=0.074) and significantly fewer vs Turbuhaler (3/60 (5%) vs 20/60 (33%), P<0.001). More asthma and COPD patients preferred ELLIPTA over the other devices (all P⩽0.002). Significantly, fewer COPD patients using ELLIPTA made critical errors after reading the PIL vs other inhalers. More asthma and COPD patients preferred ELLIPTA over comparator inhalers.
authors.affiliation: Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.|Department of Research Methodology, Measurement and Data Analysis, University of Twente, Enschede, The Netherlands.
authors.forename: Job
authors.initials: J
authors.lastname: van der Palen
authors.affiliation: Primary Care and Population Sciences, University of Southampton, Southampton, UK.|NIHR Southampton Respiratory Biomedical Research Unit, Southampton, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Thomas
authors.affiliation: Inhalation consultancy Ltd, Leeds, UK.
authors.forename: Henry
authors.initials: H
authors.lastname: Chrystyn
authors.affiliation: Respiratory Medical Franchise, GSK, Brentford, UK.
authors.forename: Raj K
authors.initials: RK
authors.lastname: Sharma
authors.affiliation: Department of Pulmonary Medicine, Medisch Spectrum Twente, Enschede, The Netherlands.
authors.forename: Paul Dlpm
authors.initials: PD
authors.lastname: van der Valk
authors.affiliation: Department of Pulmonary Medicine, Gelre Ziekenhuizen, Zutphen, The Netherlands.
authors.forename: Martijn
authors.initials: M
authors.lastname: Goosens
authors.affiliation: Clinical and Experimental Sciences, Faculty of Medicine, University of Southampton, Southampton, UK.
authors.forename: Tom
authors.initials: T
authors.lastname: Wilkinson
authors.affiliation: Minchinhampton Surgery, Stroud, UK.
authors.forename: Carol
authors.initials: C
authors.lastname: Stonham
authors.affiliation: Respiratory Department, Queen Alexandra Hospital, Portsmouth, UK.
authors.forename: Anoop J
authors.initials: AJ
authors.lastname: Chauhan
authors.affiliation: MDC Global Clinical Development UK, Respiratory R&D, GSK, Uxbridge, UK.
authors.forename: Varsha
authors.initials: V
authors.lastname: Imber
authors.affiliation: Clinical Statistics, GSK, Uxbridge, UK.
authors.forename: Chang-Qing
authors.initials: CQ
authors.lastname: Zhu
authors.affiliation: Value Evidence Outcomes Respiratory, GSK, Brentford, UK.
authors.forename: Henrik
authors.initials: H
authors.lastname: Svedsater
authors.affiliation: Respiratory Medical Franchise, GSK, Brentford, UK.
authors.forename: Neil C
authors.initials: NC
authors.lastname: Barnes
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage*; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D036501:Metered Dose Inhalers; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents