title: Asthma-Related Outcomes in Patients Initiating Extrafine Ciclesonide or Fine-Particle Inhaled Corticosteroids.
abstract: OBJECTIVE
  Extrafine-particle inhaled corticosteroids (ICS) have greater small airway deposition than standard fine-particle ICS. We sought to compare asthma-related outcomes after patients initiated extrafine-particle ciclesonide or fine-particle ICS (fluticasone propionate or non-extrafine beclomethasone).
  
  
  METHODS
  This historical, matched cohort study included patients aged 12-60 years prescribed their first ICS as ciclesonide or fine-particle ICS. The 2 cohorts were matched 1:1 for key demographic and clinical characteristics over the baseline year. Co-primary endpoints were 1-year severe exacerbation rates, risk-domain asthma control, and overall asthma control; secondary endpoints included therapy change.
  
  
  RESULTS
  Each cohort included 1,244 patients (median age 45 years; 65% women). Patients in the ciclesonide cohort were comparable to those in the fine-particle ICS cohort apart from higher baseline prevalence of hospitalization, gastroesophageal reflux disease, and rhinitis. Median (interquartile range) prescribed doses of ciclesonide and fine-particle ICS were 160 (160-160) μg/day and 500 (250-500) μg/day, respectively (P<0.001). During the outcome year, patients prescribed ciclesonide experienced lower severe exacerbation rates (adjusted rate ratio [95% CI], 0.69 [0.53-0.89]), and higher odds of risk-domain asthma control (adjusted odds ratio [95% CI], 1.62 [1.27-2.06]) and of overall asthma control (2.08 [1.68-2.57]) than those prescribed fine-particle ICS. The odds of therapy change were 0.70 (0.59-0.83) with ciclesonide.
  
  
  CONCLUSIONS
  In this matched cohort analysis, we observed that initiation of ICS with ciclesonide was associated with better 1-year asthma outcomes and fewer changes to therapy, despite data suggesting more difficult-to-control asthma. The median prescribed dose of ciclesonide was one-third that of fine-particle ICS.
authors.affiliation: University of Groningen, Department of Pulmonology, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Dirkje S
authors.initials: DS
authors.lastname: Postma
authors.affiliation: Radboud University Medical Center, Nijmegen, The Netherlands.
authors.forename: Richard
authors.initials: R
authors.lastname: Dekhuijzen
authors.affiliation: University of Groningen, Department of Pulmonology, University Medical Center Groningen, Groningen, The Netherlands.
authors.forename: Thys
authors.initials: T
authors.lastname: van der Molen
authors.affiliation: Department of Medicine, National Jewish Health, and University of Colorado Denver, Denver, CO, USA.
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Martin
authors.affiliation: Emma's Children Hospital AMC, Amsterdam, The Netherlands.
authors.forename: Wim
authors.initials: W
authors.lastname: van Aalderen
authors.affiliation: University Paris Descartes (EA2511), Cochin Hospital Group (AP-HP), Paris, France.
authors.forename: Nicolas
authors.initials: N
authors.lastname: Roche
authors.affiliation: Cincinnati Children's Hospital and Medical Center, Cincinnati, OH, USA.
authors.forename: Theresa W
authors.initials: TW
authors.lastname: Guilbert
authors.affiliation: Brigham and Women's Hospital and Harvard Medical School, Boston, MA, USA.
authors.forename: Elliot
authors.initials: E
authors.lastname: Israel
authors.affiliation: Takeda Pharmaceuticals International GmbH, Zurich, Switzerland.
authors.forename: Daniela
authors.initials: D
authors.lastname: van Eickels
authors.affiliation: Takeda Development Centre Europe Ltd, London, UK.
authors.forename: Javaria Mona
authors.initials: JM
authors.lastname: Khalid
authors.affiliation: PHARMO Institute for Drug Outcomes Research, The Netherlands.
authors.forename: Ron M C
authors.initials: RM
authors.lastname: Herings
authors.affiliation: PHARMO Institute for Drug Outcomes Research, The Netherlands.
authors.forename: Jetty A
authors.initials: JA
authors.lastname: Overbeek
authors.affiliation: Research in Real Life, Cambridge, UK.
authors.forename: Cristiana
authors.initials: C
authors.lastname: Miglio
authors.affiliation: Research in Real Life, Cambridge, UK.
authors.forename: Victoria
authors.initials: V
authors.lastname: Thomas
authors.affiliation: Research in Real Life, Cambridge, UK.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hutton
authors.affiliation: Research in Real Life, Cambridge, UK.
authors.forename: Elizabeth V
authors.initials: EV
authors.lastname: Hillyer
authors.affiliation: Research in Real Life, Cambridge, UK.|Academic Primary Care, University of Aberdeen, Aberdeen, UK. dprice@rirl.org.
authors.forename: David B
authors.initials: DB
authors.lastname: Price
keywords: Anti-asthmatic agents; comparative effectiveness research; disease exacerbation; small airway