title: Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma: an efficacy and cost-effectiveness study.
abstract: OBJECTIVE
  To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/formoterol with formoterol as needed in patients with persistent asthma.
  
  
  METHODS
  6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA).
  
  
  METHODS
  budesonide/formoterol 160/4.5 microg, one inhalation, once or twice daily maintenance plus additional doses as-needed (1 x SMART or 2 x SMART), or budesonide/formoterol 160/4.5 microg two inhalations twice daily plus formoterol 4.5 microg as needed (2 x 2 FIX + F). Children 6-11 years old used an 80/4.5 microg dose strength. Primary variables of efficacy were the changes in the Asthma Control Questionnaire (ACQ(5)) and morning peak expiratory flow (PEF).
  
  
  RESULTS
  Mean age of patients 40 years (range 6-82 years); 53% female. No differences between the groups were found in ACQ(5) scores or asthma exacerbation rates. Morning PEF was higher in the 2 x 2 FIX + F group vs. the 1 x SMART and 2 x SMART groups (differences 13 L/min and 9 L/min, respectively; p < 0.002). The 1 x SMART group showed a significant decrease in asthma controlled days compared with the two other groups. No difference was seen between the 2 x SMART group and the 2 x 2 FIX + F group. Treatment costs were significantly lower in the SMART groups compared with the 2 x 2 FIX + F group.
  
  
  CONCLUSIONS
  Compared with the 2 x 2 FIX + F treatment the use of budesonide/formoterol was 30-40% lower in the SMART groups while maintaining equal ACQ(5) scores. Daily asthma control improved equally with 2 x SMART compared to 2 x 2 FIX + F with a reduction in asthma medication cost. The one dose once daily maintenance treatment (1 x SMART) resulted in a low level of treatment failure (exacerbations) but led to more days with symptoms. Therefore, a daily dose of two inhalations seems to be the lowest appropriate dose in patients with moderate persistent asthma.
authors.affiliation: Primary Health Care Centre, Byske, Sweden.
authors.forename: Mikael
authors.initials: M
authors.lastname: Lundborg
authors.forename: Sören
authors.initials: S
authors.lastname: Wille
authors.forename: Leif
authors.initials: L
authors.lastname: Bjermer
authors.forename: Björn
authors.initials: B
authors.lastname: Tilling
authors.forename: Michael
authors.initials: M
authors.lastname: Lundgren
authors.forename: Gunilla
authors.initials: G
authors.lastname: Telg
authors.forename: Tommy
authors.initials: T
authors.lastname: Ekström
authors.forename: Olof
authors.initials: O
authors.lastname: Selroos
mesh_terms: D000280:Administration, Inhalation; D000293:Adolescent; D000328:Adult; D001249:Asthma / Q000188:drug therapy* / Q000191:economics*; D001993:Bronchodilator Agents / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D019819:Budesonide / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D002648:Child; D003362:Cost-Benefit Analysis; D004305:Dose-Response Relationship, Drug; D004359:Drug Therapy, Combination; D004983:Ethanolamines / Q000008:administration & dosage* / Q000191:economics / Q000627:therapeutic use; D000068759:Formoterol Fumarate; D017048:Health Care Costs / Q000706:statistics & numerical data*; D006801:Humans; D011788:Quality of Life; D011795:Surveys and Questionnaires
chemical_list: D001993:Bronchodilator Agents; D004983:Ethanolamines; D019819:Budesonide; D000068759:Formoterol Fumarate