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.

After 1 year, patients across all 3 strata (based on pre-study medication: ICS-naïve [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.

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.

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.