Abstract

Rationale Whether Total Control (equating to clinical remission) of asthma can be achieved has not been investigated. Gaining Optimal Asthma controL (GOAL) assessed this in a 1-year study comparing salmeterol/fluticasone (SFC) to fluticasone propionate (FP) alone. Methods Patients with uncontrolled asthma were allocated to 3 strata based upon prior medication (ICS-naïve [S1]/low-dose ICS [S2]/moderate-dose ICS [S3]), and randomized to SFC (Seretide ®/Advair ®) or FP (Flixotide ®/Flovent ®). Treatment was stepped-up every 12 weeks until Total Control was achieved (or maximum dose reached). Total Control (no symptoms, no rescue medication, no night-awakenings, no exacerbations, no emergency visits, no adverse events and normal lung function) was based on the GINA/NIH guidelines, and evaluated over the last 8 weeks of each 12 week treatment period. Results 3421 patients were randomized to treatment (mean age 40 years (SD: 16.2) and FEV 1 77% at baseline). Significantly more patients achieved Total Control with SFC compared with FP alone: S1 42% vs 31%; S2 32% vs 20%; and S3 19% vs 8%, respectively (all p<0.001). The proportion of patients achieving Total Control at the same or lower dose of ICS was significantly greater with SFC vs FP alone in each stratum; the odds ratios were: S1 1.78; S2 2.19; and S3 2.95 (all p<0.001). Conclusions These data show that the goals of the GINA/NIH guidelines can be achieved and maintained, and that this level of Total Control (equating to clinical remission) is realised in more patients with salmeterol/fluticasone than with fluticasone alone, regardless of previous treatment.

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