title: A comparison of budesonide/formoterol maintenance and reliever therapy versus conventional best practice in asthma management in Spain.
abstract: OBJECTIVE
  To study the effectiveness and safety in a real-life setting of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy® (Symbicort SMART®), a simplified management approach with one inhaler, compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.
  
  
  METHODS
  Open-label randomized controlled parallel-group trial, 6-month treatment.
  
  
  METHODS
  A total of 654 adult patients, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting β(2)-agonist.
  
  
  METHODS
  Time to first severe asthma exacerbation and number of severe asthma exacerbations.
  
  
  RESULTS
  No difference between groups was seen in time to first severe exacerbation (p = .2974). Exacerbation rates were low in both groups. A total of 22 patients in the Symbicort SMART group experienced a total of 24 severe asthma exacerbations, and 31 patients in the CBP group experienced a total of 34 severe asthma exacerbations (annual rate 0.16 vs. 0.22, p = .2869). The mean daily dose of ICS expressed in beclomethasone dipropionate equivalent was significantly lower in the Symbicort SMART group (including as-needed use) versus the CBP group (799 μg vs.1184 μg; p < .001). Mean scores in Asthma Control Questionnaire, five-question version, improved significantly in the SMART group compared with the CBP group (p = .0292). Symbicort SMART and CBP were equally well tolerated. The mean drug cost per patient per 6 months was lower for the patients in the SMART group compared with patients receiving CBP (€295.32 vs. €387.98, p < .0001).
  
  
  CONCLUSIONS
  A simplified regimen using budesonide/formoterol maintenance and reliever therapy (Symbicort SMART) was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and lower drug costs.
authors.affiliation: Department of Allergy, Hospital La Paz, IdiPAZ, Madrid, Spain. squirce.hulp@salud.madrid.org
authors.forename: Santiago
authors.initials: S
authors.lastname: Quirce
authors.forename: Carlos
authors.initials: C
authors.lastname: Barcina
authors.forename: Vicente
authors.initials: V
authors.lastname: Plaza
authors.forename: Eduardo
authors.initials: E
authors.lastname: Calvo
authors.forename: Mercedes
authors.initials: M
authors.lastname: Muñoz
authors.forename: Rubén
authors.initials: R
authors.lastname: Ampudia
authors.forename: Margarita
authors.initials: M
authors.lastname: Capel
mesh_terms: D000293:Adolescent; D000305:Adrenal Cortex Hormones / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018927:Anti-Asthmatic Agents / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D001249:Asthma / Q000188:drug therapy* / Q000191:economics / Q000503:physiopathology; D019819:Budesonide / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines / Q000009:adverse effects / Q000191:economics / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D012129:Respiratory Function Tests; D013030:Spain; D011795:Surveys and Questionnaires; D055815:Young Adult
chemical_list: D000305:Adrenal Cortex Hormones; D018927:Anti-Asthmatic Agents; D000069502:Budesonide, Formoterol Fumarate Drug Combination; D004338:Drug Combinations; D004983:Ethanolamines; D019819:Budesonide