title: Comparison of serious inhaler technique errors made by device-naïve patients using three different dry powder inhalers: a randomised, crossover, open-label study.
abstract: BACKGROUND
  Serious inhaler technique errors can impair drug delivery to the lungs. This randomised, crossover, open-label study evaluated the proportion of patients making predefined serious errors with Pulmojet compared with Diskus and Turbohaler dry powder inhalers.
  
  
  METHODS
  Patients ≥18 years old with asthma and/or COPD who were current users of an inhaler but naïve to the study devices were assigned to inhaler technique assessment on Pulmojet and either Diskus or Turbohaler in a randomised order. Patients inhaled through empty devices after reading the patient information leaflet. If serious errors potentially affecting dose delivery were recorded, they repeated the inhalations after watching a training video. Inhaler technique was assessed by a trained nurse observer and an electronic inhalation profile recorder.
  
  
  RESULTS
  Baseline patient characteristics were similar between randomisation arms for the Pulmojet-Diskus (n = 277) and Pulmojet-Turbohaler (n = 144) comparisons. Non-inferiority in the proportions of patients recording no nurse-observed serious errors was demonstrated for both Pulmojet versus Diskus, and Pulmojet versus Turbohaler; therefore, superiority was tested. Patients were significantly less likely to make ≥1 nurse-observed serious errors using Pulmojet compared with Diskus (odds ratio, 0.31; 95 % CI, 0.19-0.51) or Pulmojet compared with Turbohaler (0.23; 0.12-0.44) after reading the patient information leaflet with additional video instruction, if required.
  
  
  CONCLUSIONS
  These results suggest Pulmojet is easier to learn to use correctly than the Turbohaler or Diskus for current inhaler users switching to a new dry powder inhaler.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01794390 (February 14, 2013).
authors.affiliation: Inhalation Consultancy Ltd, Yeadon, Leeds, West Yorkshire, UK.|Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.
authors.forename: Henry
authors.initials: H
authors.lastname: Chrystyn
authors.affiliation: Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK. dprice@rirl.org.|Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK. dprice@rirl.org.
authors.forename: David B
authors.initials: DB
authors.lastname: Price
authors.affiliation: Department of Medical Pharmacology, CHU et Univ. de Bordeaux, Bordeaux, France.
authors.forename: Mathieu
authors.initials: M
authors.lastname: Molimard
authors.affiliation: Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Polwarth Building, Foresterhill, Aberdeen, AB25 2ZD, UK.
authors.forename: John
authors.initials: J
authors.lastname: Haughney
authors.affiliation: Woolcock Institute of Medical Research, Sydney Medical School, University of Sydney and Sydney Local Health District, Sydney, Australia.
authors.forename: Sinthia
authors.initials: S
authors.lastname: Bosnic-Anticevich
authors.affiliation: Department of Experimental and Clinical Medicine, Careggi University Hospital, Florence, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Lavorini
authors.affiliation: Horizon Respiratory Consultancy, Oxford, UK.
authors.forename: John
authors.initials: J
authors.lastname: Efthimiou
authors.affiliation: Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.
authors.forename: Dawn
authors.initials: D
authors.lastname: Shan
authors.affiliation: Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.|Norwich Medical School, University of East Anglia, Norwich Research Park, Norwich, UK.
authors.forename: Erika
authors.initials: E
authors.lastname: Sims
authors.affiliation: Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.
authors.forename: Anne
authors.initials: A
authors.lastname: Burden
authors.affiliation: Research in Real-Life, 5a Coles Lane, Oakington, Cambridge, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hutton
authors.affiliation: University Paris Descartes (EA2511), Respiratory and Intensive Care Medicine Department, Cochin Hospital Group, AP-HP, Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Roche
mesh_terms: D000280:Administration, Inhalation; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage*; D000318:Adrenergic beta-Agonists / Q000008:administration & dosage*; D000328:Adult; D000368:Aged; D001249:Asthma / Q000188:drug therapy*; D018592:Cross-Over Studies; D058995:Dry Powder Inhalers; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D016017:Odds Ratio; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
chemical_list: D000305:Adrenal Cortex Hormones; D000318:Adrenergic beta-Agonists