title: Real-life use of budesonide/formoterol in clinical practice: a 12-month follow-up assessment in a multi-national study of asthma patients established on single-inhaler maintenance and reliever therapy.
abstract: OBJECTIVE
  The efficacy and safety of budesonide/formoterol maintenance and reliever therapy (MRT) has been demonstrated in phase III clinical studies, but limited data are available in a real-life setting. We examined the pattern of maintenance and as-needed inhaler use in routine clinical practice among patients with asthma receiving budesonide/formoterol MRT (NCT00505388).
  
  
  METHODS
  This 12-month European observational study enrolled patients prescribed budesonide/formoterol MRT and grouped them based on regimen: 80/4.5 μg one inhalation twice daily (b.i.d.); 160/4.5 μg one inhalation b.i.d.; 160/4.5 μg two inhalations b.i.d. (all plus as needed). Patient data were collected daily using an interactive voice- or web-response system. The primary outcome measure was total number of budesonide/formoterol inhalations/day.
  
  
  RESULTS
  Overall, 4,581 patients were included (64% female; mean age 48.4 years; regimen: 80/4.5 μg, n = 119; 160/4.5 μg, n = 3,106; 2 x 160/4.5 μg, n = 1,355). Mean (median) total numbers of budesonide/formoterol inhalations/day were 2.48 (2.11), 2.53 (2.14), and 4.27 (4.05) for 80/4.5 μg b.i.d., 160/4.5 μg b.i.d., and 2 x 160/4.5 μg b.i.d., respectively; corresponding mean (median) number of as-needed inhalations/day were 0.68 (0.17), 0.73 (0.26), and 1.08 (0.45), respectively. As-needed budesonide/formoterol use was generally low with a mean of 61 - 66% of reliever-free days; over 4 reliever inhalations/day occurred on a mean of 0.4 - 2.5% of days for all budesonide/formoterol MRT regimens.
  
  
  CONCLUSIONS
  Inroutine clinical practice, all budesonide/formoterol MRT regimens were associated with a high proportion of reliever-free days and low incidence of high reliever-use days, indicating acceptable levels of asthma control with this symptom-adjusted controller regimen.
authors.forename: Björn
authors.initials: B
authors.lastname: Ställberg
authors.forename: Ian
authors.initials: I
authors.lastname: Naya
authors.forename: Jan
authors.initials: J
authors.lastname: Ekelund
authors.forename: Göran
authors.initials: G
authors.lastname: Eckerwall
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D058666:Adrenergic beta-2 Receptor Agonists / Q000008:administration & dosage* / Q000009:adverse effects; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001249:Asthma / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000009:adverse effects; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D005060:Europe; D005260:Female; D005500:Follow-Up Studies; D000068759:Formoterol Fumarate; D005938:Glucocorticoids / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D058666:Adrenergic beta-2 Receptor Agonists; D001993:Bronchodilator Agents; D004338:Drug Combinations; D004983:Ethanolamines; D005938:Glucocorticoids; D019819:Budesonide; D000068759:Formoterol Fumarate