The STAY Study

Design

The STAY study by O’Byrne and colleagues [1] was a 12-month, double-blind, randomised, parallel-group study comparing the efficacy and safety of Symbicort SMART® with same maintenance dose Symbicort plus a short-acting β2-agonist (SABA) or higher maintenance dose budesonide plus a SABA as needed.

Patients (N = 2760) with asthma aged 4–80 years (forced expiratory volume in 1 second [FEV1] 60–100% predicted normal) were randomised to receive Symbicort SMART (80/4.5 µg twice daily plus as needed), same maintenance dose Symbicort® (80/4.5 µg twice daily) plus SABA as needed, or higher maintenance dose inhaled corticosteroid (ICS: budesonide, 320 µg twice a day) plus SABA as needed. Children (aged 4–11 years) used a once-daily maintenance dose. The primary outcome was time to first severe exacerbation.

Results

The STAY study showed that Symbicort SMART significantly reduced severe exacerbations and the need for oral steroids, and improved current asthma control when compared with Symbicort or a fourfold higher maintenance dose of budesonide, both with SABA for relief.

• Symbicort SMART significantly prolonged time to first severe exacerbation (P < 0.001) resulting in a 45–47% lower exacerbation risk versus Symbicort plus SABA or higher maintenance dose budesonide plus SABA.
• Time to second and third exacerbations was also significantly prolonged with Symbicort SMART compared with both alternative regimens.
• Improvements in morning and evening peak expiratory flow (PEF) and FEV1 were significantly greater with Symbicort SMART versus both alternative regimens. In addition, Symbicort plus SABA significantly improved morning and evening PEF versus budesonide plus SABA.
• All treatments improved asthma symptoms but improvements in night-time symptoms and awakenings were significantly greater in patients using Symbicort SMART (all P < 0.05) and resulted in 14 extra nights per year free from awakenings compared with both comparators.
• Improvements in daytime and night-time symptoms (P < 0.05) and asthma control days (P < 0.001) were also greater with Symbicort SMART versus higher maintenance dose budesonide plus SABA.
• The mean number of reliever inhalations were significantly lower with Symbicort SMART than either comparator using SABA for relief (all P < 0.001) and patients using Symbicort SMART also had fewer courses of oral steroids compared with the two comparator groups.
• All treatments were well tolerated

References

1. O'Byrne PM, Bisgaard H, Godard PP, et al. Budesonide/formoterol combination therapy as both maintenance and reliever medication in asthma. Am J Respir Crit Care Med 2005;171(2): 129-36.