Efficacy of Seretide Multidisk combination therapy in patients with moderate asthma (the results of open comparative randomized multicenter study "ADULT-STEP")

Abstract

This trial was aimed to researching an efficacy of the Seretide Multidisk combinated therapy in patients with moderate bronchial asthma.
The "Adult-step" program was designed as a randomized opened comparative multi-center trial. It involved 65 patients with moderate asthma aged 16 to 50 years divided into two groups. The 1^st group patients have received fluticazone propionate 500 meg daily for all the treatment period (5 months) that was the "step up" mode. The 2^nd group patients have received Seretide Multidisk 250/50 meg twice a day for 12 weeks, then they were changed the treatment to the fluticazone propionate 500 meg daily that was the "step down" mode. The control of asthma was assessed in 8 weeks by the E.Bateman's criteria. The 2^nd group patients with unsatisfactory effect were expelled from the study, those of the 1st group were transferred to the "step down" mode. The study protocol included an assessment of the main asthma signs, respiratory function parameters, severity of post-exertion bronchoconstruction.
At the end of the trial 69.7% of patients taking Seretide Multidisk (the 2^nd group) and 28.1% of the patients taking fluticazone propionate (the 1^st group) achieved the asthma symptoms control according to the E.Bateman's criteria. So, the initial therapy with Seretide Multidisk was more effective than the "step up" pharmacological mode in moderate asthma patients.