The Szafranski study design
The study by Szafranski and colleagues [1] was a 12-month, randomised, double-blind, placebo-controlled study involving 812 patients with moderate to severe COPD (forced expiratory volume in 1 second [FEV1] < 50% predicted normal), designed to evaluate the efficacy and safety of Symbicort® compared with budesonide, formoterol and placebo.
Following a 2-week run in, patients were randomised to two inhalations twice daily of Symbicort (160/4.5 μg), budesonide (200 μg), formoterol (4.5 μg) or placebo. All patients used terbutaline as needed for symptom relief. The primary efficacy variables were the number of severe exacerbations and FEV1.
The Szafranski study results
Szafranski et al showed that Symbicort reduced exacerbations and provided early and sustained improvements in lung function and symptoms, together with improvements in health-related quality of life.
- The number of severe exacerbations per patient per year was 1.42, 1.59, 1.84 and 1.87 in the Symbicort, budesonide, formoterol and placebo groups, respectively.
- Symbicort significantly reduced the rate of severe exacerbations by 24% and 23% compared with placebo and formoterol, respectively (both P < 0.05).
- Patients in the Symbicort group had fewer courses of oral steroids per patient per year used in association with severe exacerbations than those in the formoterol or placebo groups (28% and 31% reduction, respectively; both P < 0.05).
- Symbicort achieved a sustained improvement in FEV1 throughout the study period, by 15% and 9% compared with placebo and budesonide (both P < 0.001).
- Symbicort achieved significantly greater and sustained improvements in morning and evening peak expiratory flow compared with other treatment comparators (all P < 0.001).
- Treatment with Symbicort resulted in an improvement of 3.9 points in the St Georges Respiratory Questionnaire compared with placebo (P < 0.009: a clinically relevant change is defined as 4.0 points).
- All treatments were well tolerated and had similar adverse event profiles.
Szafranski study: Symbicort improves morning PEF [1]
References
- Szafranski W, Cukier A, Ramirez A, et al. Efficacy and safety of budesonide/formoterol in the management of chronic obstructive pulmonary disease. Eur Respir J 2003; 21:74–81.
