title: Budesonide/formoterol maintenance and reliever therapy versus conventional best standard treatment in asthma in an attempted 'real life' setting.
abstract: OBJECTIVE
  The purpose of this study was to compare the efficacy of budesonide/formoterol maintenance and reliever therapy (Symbicort® SMART®, AstraZeneca AB, Södertälje, Sweden) with conventional best standard treatment (CBST) in patients with persistent asthma in an attempted 'real life' setting.
  
  
  METHODS
  In total, 1835 patients from Denmark, Finland and Norway were randomized to 26 weeks treatment with budesonide/formoterol 160/4,5 µg twice daily plus budesonide/formoterol 160/4,5 µg for symptom relief or CBST according to the Global Initiative for Asthma guidelines. The study was randomized, open-label and designed to reflect 'real life' asthma management. Efficacy variables were time to first severe asthma exacerbation, rate of severe asthma exacerbations, asthma control (Asthma Control Questionnaire-5) and use of inhaled glucocorticosteroids (IGCS).
  
  
  RESULTS
  Treatment with budesonide/formoterol maintenance and reliever therapy led to a 21% reduction in time to first severe asthma exacerbation compared with CBST, although not statistically significant (hazard ratio 0.794, P = 0.189). A trend towards a reduction in the rate of severe exacerbations in the budesonide/formoterol maintenance and reliever therapy group was observed (16 vs 22 events/100 patient years; P = 0.058). The percentage of patients with well-controlled asthma increased significantly among those treated with budesonide/formoterol maintenance and reliever therapy compared with CBST (45% vs 40%; odds ratio 1.39; P < 0.01), in spite of a significant 31% reduction in total mean daily IGCS dose (P < 0.0001). No difference in mean as-needed medication use was seen (P = 0.98). All treatments were well tolerated.
  
  
  CONCLUSIONS
  Budesonide/formoterol maintenance and reliever therapy resulted in a better overall asthma control with a significant lower daily IGCS dose compared with CBST.
authors.affiliation: Respiratory and Allergy Unit, Medical Department, Roskilde Sygehus, University of Copenhagen, Roskilde, Denmark.
authors.forename: Ulrik
authors.initials: U
authors.lastname: Søes-Petersen
authors.forename: Tuomo
authors.initials: T
authors.lastname: Kava
authors.forename: Ragnar
authors.initials: R
authors.lastname: Dahle
authors.forename: Yao
authors.initials: Y
authors.lastname: Lei
authors.forename: Nanna
authors.initials: N
authors.lastname: Dam
mesh_terms: D000280:Administration, Inhalation; D000284:Administration, Oral; D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000008:administration & dosage; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D001249:Asthma / Q000188:drug therapy* / Q000503:physiopathology; D019819:Budesonide / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D004334:Drug Administration Schedule; D004338:Drug Combinations; D004983:Ethanolamines / Q000008:administration & dosage* / Q000009:adverse effects; D000068759:Formoterol Fumarate; D006801:Humans; D008168:Lung / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D012107:Research Design; D012720:Severity of Illness Index; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate