Design
The COMPASS study by Kuna and colleagues [1] was a randomised, double-blind, 6-month clinical asthma trial comparing the efficacy and safety of Symbicort SMART® with more traditional treatment approaches using a higher fixed maintenance dose of Seretide™ (salmeterol/fluticasone: at its most frequently prescribed dose) and a higher fixed maintenance dose of Symbicort (at double the maintenance dose). Both fixed-dose regimens used a short-acting β2-agonist (SABA) for symptom relief.
Following a 2-week run in, 3335 symptomatic adults and adolescents (mean forced expiratory volume in 1 second (FEV1) 73% predicted normal, mean inhaled corticosteroid (ICS) dose 745 µg/day) with asthma were randomised to receive Symbicort SMART (160/4.5 µg one inhalation twice daily plus as needed), salmeterol/fluticasone (25/125 µg two inhalations twice daily plus as-needed terbutaline) or Symbicort (320/9 µg one inhalation twice daily plus as-needed terbutaline). The primary variable was time to first severe exacerbation.
Results
The COMPASS study showed that Symbicort SMART reduces asthma exacerbations and maintains similar daily asthma control at a lower overall drug load compared with higher maintenance dose Seretide and Symbicort.
- Symbicort SMART significantly prolonged the time to first severe exacerbation versus higher maintenance dose Seretide or Symbicort (P = 0.0034 and P = 0.023 respectively).
- Symbicort SMART reduced the risk of first severe exacerbation by 26–33% and the rate of severe exacerbations by 28–39% compared with the two higher maintenance dose ICS/long-acting β2-agonist (LABA) combination therapies plus SABA.
- Symbicort SMART reduced the number of days with severe exacerbations requiring treatment by 38–61% compared with comparator therapies.
- All treatments were well tolerated
COMPASS STUDY: Symbicort SMART significantly reduces exacerbations compared with higher maintenance doses of fixed ICS/LABA plus SABA [1]
References
- Kuna P, Peters MJ, Manjra AI, et al. Effect of budesonide/formoterol maintenance and reliever therapy on asthma exacerbations. Int J Clin Pract 2007; 61:725–736.
