title: Effectiveness and safety of ciclesonide in the treatment of patients with persistent allergic or non-allergic asthma in medical practice (Data from a non-interventional study conducted in Austria).
abstract: BACKGROUND
  Effectiveness and safety profile of ciclesonide in the treatment of persistent allergic or non-allergic asthma was evaluated in real-life setting in Austria.
  
  
  METHODS
  Prospective, single-arm, 3-month observational, non-interventional, open-label cohort study in patients with persistent asthma (with or without allergic component) of any severity grade was conducted. Patients were either treatment naïve or switched to treatment with ciclesonide and had an indication for treatment with inhaled corticosteroids.
  
  
  RESULTS
  In all, 307 patients (50.8% female; mean age, 45.7 years) were prescribed ciclesonide. After 3 months of observation, the percentage of patients with daily symptoms had declined from 33.2 to 3.9%, night-time symptoms from 21.8 to 5.2%, physical activity limitations from 73.9 to 24.4%, and rescue medication usage from 70.0 to 45.9%. The mean total Asthma Control Questionnaire (ACQ) score was 2.32 ± 1.14 at the first and 1.08 ± 0.88 at the final visit. The number of patients with well-controlled asthma (ACQ score < 1) increased considerably from 11.0% at baseline to 52.2% at study end. Clinically important mean improvements were observed in the total self-assessed Asthma Quality of Life score and all four domain scores. The mean forced expiratory volume in 1 s (FEV1) increased by 0.3 L from 2.60 ± 0.87 L to 2.89 ± 0.86 L, and the mean FEV1% predicted increased from 75.1 ± 15.4% to 83.7 ± 14.9%. Incidence of adverse drug reactions (ADRs) was low (4 ADRs in 3 of 307 patients, or 1.0%).
  
  
  CONCLUSIONS
  This study confirmed the effectiveness and safety of ciclesonide under routine conditions in Austria. Improvements in symptom control, lung function, and quality of life were observed. Ciclesonide was well tolerated.
authors.affiliation: Ludwig Boltzmann Institute for COPD and Respiratory Epidemiology, Department of Respiratory and Critical Care Medicine, Otto-Wagner-Hospital, Baumgartner Höhe 1, 1145, Vienna, Austria, otto.burghuber@wienkav.at.
authors.forename: Otto Chris
authors.initials: OC
authors.lastname: Burghuber
authors.forename: Gerhard
authors.initials: G
authors.lastname: Köberl
authors.forename: Susanna
authors.initials: S
authors.lastname: Lenk-Feik
authors.forename: Monika
authors.initials: M
authors.lastname: Schantl
authors.forename: Peter
authors.initials: P
authors.lastname: Sander
authors.forename: Alexandra
authors.initials: A
authors.lastname: Hammer
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018926:Anti-Allergic Agents / Q000008:administration & dosage / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy*; D001317:Austria; D002908:Chronic Disease; D015331:Cohort Studies; D005260:Female; D006801:Humans; D006967:Hypersensitivity / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D011282:Pregnenediones / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018926:Anti-Allergic Agents; D011282:Pregnenediones; C120481:ciclesonide