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The STEP Study
Design
The STEP study by Scicchitano and colleagues [1] was a 12-month, randomised, double-blind, parallel-group study comparing the efficacy and safety of Symbicort SMART® with a higher maintenance dose of budesonide in patients with asthma.
Patients (N = 1890; mean age 43 years, mean baseline forced expiratory volume in 1 second [FEV1] 70% predicted normal, mean inhaled corticosteroid [ICS] dose 746 µg/day) were randomised to receive either budesonide (160 µg, two inhalations twice daily) plus terbutaline 0.4 mg as needed or Symbicort SMART (160/4.5 µg, two inhalations once daily plus as needed). Time to first severe exacerbation was the primary outcome variable.
Results
The STEP study showed that Symbicort SMART was as well tolerated as a higher fixed dose of budesonide plus as-needed short-acting β2-agonist while providing superior asthma control and reducing the risk of severe asthma exacerbations.
- Symbicort SMART significantly prolonged the time to first severe exacerbation and reduced the risk of having a severe exacerbation by 39% compared with a higher dose of budesonide (both P < 0.001).
- Compared with budesonide, Symbicort SMART resulted in 45% fewer severe exacerbations requiring medical intervention per patient (P < 0.001), fewer hospitalisations/emergency room treatments (15 versus 25 events, respectively) and fewer treatment days with systemic steroids (1776 days versus 3177 days, respectively).
- Symbicort SMART patients used less as-needed medication (0.90 versus 1.42 inhalations/day; P < 0.001) and had a lower mean daily ICS dose (466 μg/day versus 640 μg/day) versus budesonide.
- Over the 12-month study period, on 60% of days, patients in the Symbicort SMART group did not require any additional as-needed medication.
- Symbicort SMART gave 31 more asthma control days (a night and day with no asthma symptoms and no as-needed medication use) per patient-year and 12 extra undisturbed nights per patient-year compared with budesonide.
- Both treatments were well tolerated.
References
- Scicchitano R, Aalbers R, Ukena D, et al Efficacy and safety of budesonide/formoterol single inhaler therapy versus a higher dose of budesonide in moderate to severe asthma. Curr Med Res Opin 2004; 20:1403–1418.
