title: Real-Life Outcomes for Patients with Asthma Prescribed Spacers for Use with Either Extrafine- or Fine-Particle Inhaled Corticosteroids.
abstract: BACKGROUND
  Spacers are often used with pressurized metered-dose inhalers (pMDIs) to eliminate the need for coordinating inhalation with actuation.
  
  
  OBJECTIVE
  To investigate the real-life effectiveness of spacers prescribed for use with either extrafine- or fine-particle inhaled corticosteroids (ICSs).
  
  
  METHODS
  This historical matched cohort study examined anonymous medical record data over 2 years (1-year baseline, 1-year outcome) for patients with asthma aged 12 to 80 years initiating ICSs by pMDI with or without prescribed spacer. We compared outcomes for spacer versus no-spacer arms, matched for key baseline and asthma-related characteristics, within 2 ICS cohorts: (1) extrafine-particle ICS (beclomethasone) and (2) fine-particle ICS (fluticasone). Effectiveness end points were compared using conditional regression methods.
  
  
  RESULTS
  Matched spacer and no-spacer arms of the extrafine-particle ICS cohort each included 2090 patients (69% females; median age, 46-47 years) and the 2 arms of the fine-particle ICS cohort each included 444 patients (67% females; median age, 45 years). With extrafine-particle ICS, we observed no significant difference between spacer and no-spacer arms in severe exacerbation rate (primary end point): adjusted rate ratio, 1.01 (95% CI, 0.83-1.23). With fine-particle ICS, the severe exacerbation rate ratio with spacers was 0.77 (0.47-1.25). Oropharyngeal candidiasis incidence was low and similar in spacer and no-spacer arms for both ICS cohorts.
  
  
  CONCLUSIONS
  We found no evidence that prescribed spacer devices are associated with improved asthma outcomes for extrafine- or fine-particle ICS administered by pMDI. These findings challenge long-standing assumptions that spacers should improve pMDI effectiveness and indicate the need for pragmatic trials of spacers in clinical practice.
authors.affiliation: Cincinnati Children's Hospital and Medical Center, Cincinnati, Ohio.
authors.forename: Theresa W
authors.initials: TW
authors.lastname: Guilbert
authors.affiliation: Global Medicines Development, AstraZeneca, Gaithersburg, Md.
authors.forename: Gene
authors.initials: G
authors.lastname: Colice
authors.affiliation: Blizard Institute, Queen Mary University London, London, United Kingdom.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Grigg
authors.affiliation: Department of Pediatric Respiratory Medicine and Allergy, Emma Children's Hospital AMC, Amsterdam, the Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: van Aalderen
authors.affiliation: Department of Medicine, National Jewish Health, and University of Colorado Denver, Denver, Colo.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Martin
authors.affiliation: Brigham and Women's Hospital and Harvard Medical School, Boston, Mass.
authors.forename: Elliot
authors.initials: E
authors.lastname: Israel
authors.affiliation: University of Groningen, Department of Pulmonary Medicine and Tuberculosis, University Medical Center Groningen, Groningen, the Netherlands.
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.affiliation: Respiratory and Intensive Care Medicine, Cochin Hospital Group, AP-HP, University of Paris Descartes (EA2511), Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Roche
authors.affiliation: Boston Children's Hospital and Harvard Medical School, Boston, Mass.
authors.forename: Wanda
authors.initials: W
authors.lastname: Phipatanakul
authors.affiliation: Observational and Pragmatic Research Institute Pte Ltd, Singapore.
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Hillyer
authors.affiliation: Observational and Pragmatic Research Institute Pte Ltd, Singapore.
authors.forename: Jennifer M
authors.initials: JM
authors.lastname: Evans
authors.affiliation: Faculty of Health Sciences, McMaster University, Hamilton, Ontario, Canada.
authors.forename: Myrna B
authors.initials: MB
authors.lastname: Dolovich
authors.affiliation: Observational and Pragmatic Research Institute Pte Ltd, Singapore; Academic Primary Care, Division of Applied Health Sciences, University of Aberdeen, Aberdeen, United Kingdom. Electronic address: dprice@rirl.org.
authors.forename: David B
authors.initials: DB
authors.lastname: Price
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage* / Q000737:chemistry / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000737:chemistry / Q000627:therapeutic use; D001249:Asthma / Q000188:drug therapy*; D002648:Child; D005260:Female; D006801:Humans; D036503:Inhalation Spacers / Q000706:statistics & numerical data*; D008297:Male; D008875:Middle Aged; D010316:Particle Size; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents
keywords: Asthma; Inhaled corticosteroid; Particle size; Pressurized metered-dose inhaler; Spacer device