The STEAM Study

Design

The STEAM study by Rabe and colleagues [1] was a 6-month, randomised, double-blind, parallel-group study in patients with asthma comparing the efficacy and safety of Symbicort SMART® with a higher maintenance dose of budesonide plus as needed terbutaline.

Following a 2-week run-in period, 697 patients (mean age, 38 years; mean baseline forced expiratory volume in 1 second [FEV1], 75% predicted normal; mean inhaled corticosteroid [ICS] dosage, 348 µg/day) were randomised to receive Symbicort SMART (80/4.5 µg, two inhalations once daily plus as needed) or budesonide (160 µg, two inhalations once daily) plus terbutaline (0.4 mg) as needed. The primary efficacy variable was morning peak expiratory flow (PEF).

Results

The STEAM study showed that Symbicort SMART improves asthma control with a lower steroid load compared with a higher maintenance dose of budesonide plus terbutaline as needed.

• Patients in the Symbicort SMART arm achieved greater improvements in morning PEF compared with the budesonide arm (34.5 l/min versus 9.5 l/min, respectively; P < 0.001).
• Symbicort SMART reduced the risk of having a severe exacerbation by 54% lower versus budesonide (P = 0.0011) and decreased the number of hospitalisations/emergency room treatments due to asthma by 90% (1 versus 10, respectively; P = 0.026).
• The improved current asthma control seen with Symbicort SMART was achieved using a lower daily ICS dose compared with the budesonide group (240 µg versus 320 µg, respectively) and with 77% fewer oral steroid treatment days (114 versus 498 days, respectively).
• Both treatments were well tolerated.

References

1. Rabe KF, Pizzichini E, Stallberg B, et al. Budesonide/formoterol in a single inhaler for maintenance and relief in mild-to-moderate asthma: a randomised, double-blind trial. Chest 2006;129(2): 246-56.