New conception of combined drugs administration in therapy of bronchial asthma. The CONCEPT trial

Abstract

The article is devoted to the improvement in therapy of bronchial asthma, namely to achievement and maintenance of the control of the disease using combined drugs containing inhaled steroids and long-acting β₂-agonists. We used data of multi-center, randomised, double-blind, double-masking 1-year trial CONCEPT. We demonstrated advantages of therapy with fixed-dosed Seretid (fluticasone propionate / salmeterol) compared to flexible dosed Simbicort (budesonide / formoterol). As a result of this trial, the fixed-dosed Seretid was shown to provide more symptom-free days (medians, 73.8 % and 64.9 %, respectively, p = 0.03); days without emergency drug needed (94.5 % and 90.7 %, respectively, p = 0.008); better morning peak expiratory flow rate (the corrected mean, 9.5 L / min; 95%CI, 2.7–16.3, p = 0.006), approximately two-fold decrease in moderate to severe acute exacerbation rate compared to the flexible dosing of Simbicort (the corrected exacerbation rate per year, 0.18 and 0.33, p = 0.008). The total length of therapy with systemic steroids at the Seretid group was 46 % less than that at the Simbicort group (301 and 559 days, respectively, р = 0.026).