The effect of oral corticosteroids and high-dose combination therapy on achieving control of refractory asthma

Abstract Rationale The need for oral corticosteroids (OCS) in the maintenance treatment of asthma is infrequent and generally reserved for patients with refractory disease. In a sub-population of patients with refractory asthma in the Gaining Optimal Asthma controL (GOAL) study, the efficacy of adding OCS to high-dose combination therapy on achieving asthma control was assessed. Methods After 1 year, patients across all 3 strata (based on pre-study medication: ICS-naive [S1]; low-dose ICS [S2]; moderate-dose ICS [S3]) who had not achieved Total Control on either salmeterol/fluticasone propionate (Seretide ® /Advair ® ; SFC) 50/500μg bid or fluticasone (Flixotide ® /Flovent ® ; FP) 500μg bid, entered an open-label phase. 10 days of oral prednisolone (0.5mg/kg/day up to 60mg/day) was administered along with 4 weeks of SFC 50/500μg bid. The achievement of Total Control and Well-Controlled asthma based on a composite measure derived from 7 goals of the GINA/NIH guidelines was assessed over 4 weeks. Results 1462 patients received OCS+SFC (803 previously on FP alone, 659 previously on SFC). The use of OCS+SFC resulted in Total Control for an additional 35, 54 and 63 patients previously on FP and an additional 25, 37, 31 patients previously on SFC (S1/S2/S3, respectively). The number of patients achieving Well-Controlled status (for each stratum) with OCS+SFC were 40, 52, 59 for patients previously on FP, and 25, 23, 39 for patients previously on SFC. Conclusions A short course of high-dose OCS to patients on SFC 50/500 resulted in few additional responders, with a higher number of responders in patients receiving OCS+SFC who had previously received FP alone.