A comparison of budesonide/formoterol maintenance and reliever therapy vs. conventional best practice in asthma management

Int J Clin Pract. 2009 Oct;63(10):1479-88. doi: 10.1111/j.1742-1241.2009.02185.x.


Objective: To study the effectiveness and safety of budesonide/formoterol (Symbicort) Maintenance And Reliever Therapy (Symbicort SMART, AstraZeneca, Södertalje, Sweden), a simplified management approach with one inhaler compared with conventional best practice (CBP) with multiple inhalers in patients with persistent asthma.

Design: Open-label randomised controlled parallel group trial, 6-month treatment.

Participants: A total of 908 patients > or = 12 years of age, with persistent asthma receiving treatment with inhaled corticosteroids (ICS), either alone or in conjunction with long-acting beta(2)-agonist.

Main outcome measures: 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 = 0.75). Exacerbation rates were low in both groups. A total of 12 patients in the Symbicort SMART group experienced a total of 14 severe asthma exacerbations, and 19 patients in the CBP group experienced a total of 25 severe asthma exacerbations (annual rate 0.07 vs. 0.13 p = 0.09). The mean daily dose of ICS expressed in BDP equivalent was significantly lower in the Symbicort SMART group (including as-needed use) vs. in the CBP group (749 microg vs. 1059 microg; p < 0.0001). Mean scores in Asthma Control Questionnaire, 5 question version improved significantly in the SMART group compared with the CBP group (p = 0.0026). Symbicort SMART and CBP were equally well tolerated. The mean drug cost/patient/month was significantly lower for the patients in the Symbicort SMART group compared with patients receiving CBP (51.3 euros vs. 66.5 euros; p < 0.0001).

Conclusions: In Belgian patients, a simplified regimen using budesonide/formoterol maintenance and reliever therapy was at least as effective at improving clinical control compared with CBP with a significantly lower ICS dose and significantly lower drug costs.

Trial registration: ClinicalTrials.gov NCT00290264.

Publication types

  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial

MeSH terms

  • Administration, Inhalation
  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Anti-Asthmatic Agents / administration & dosage*
  • Anti-Asthmatic Agents / economics
  • Asthma / drug therapy*
  • Asthma / economics
  • Budesonide / administration & dosage*
  • Budesonide / economics
  • Child
  • Drug Costs
  • Ethanolamines / administration & dosage*
  • Ethanolamines / economics
  • Female
  • Forced Expiratory Volume / physiology
  • Formoterol Fumarate
  • Humans
  • Male
  • Middle Aged
  • Nebulizers and Vaporizers
  • Patient Satisfaction
  • Peak Expiratory Flow Rate / physiology
  • Recurrence
  • Treatment Outcome
  • Young Adult


  • Anti-Asthmatic Agents
  • Ethanolamines
  • Budesonide
  • Formoterol Fumarate

Associated data

  • ClinicalTrials.gov/NCT00290264