Salmeterol/fluticasone and fluticasone alone are well tolerated over 1 year of treatment stepped-up to achieve total control: Safety results of the GOAL study

Abstract Rationale The 1-year Gaining Optimal Asthma controL (GOAL) study showed that more patients achieve guideline-defined control with salmeterol/fluticasone (SFC) than fluticasone (FP) alone. The GOAL study provides an opportunity to evaluate safety parameters following long-term treatment stepped-up to achieve total asthma control. Methods Patients with uncontrolled asthma were stratified on prior medication (S1: ICS-naive; S2: low-dose ICS; S3: moderate-dose ICS), and randomized to SFC (Seretide ® /Advair ® ) 50/100-50/500 μg bid or FP (Flixotide ® /Flovent ® ) 100-500 μg bid for up to 1 year. Adverse events (AEs) were recorded at each clinic visit and 24-hour urinary free cortisols monitored in a patient subset. Results The safety population for SFC vs FP included: S1, 548 vs 550; S2, 585 vs 578; S3, 576 vs 579 patients. The overall incidence of AEs was similar across all strata for both SFC vs FP: S1, 55% vs 56%; S2, 60% vs 57%; and S3, 69% vs 67%. Drug-related AEs were seen in 10% of patients with both treatments (all strata). The incidence of serious AEs with SFC vs FP alone was low across all strata: S1 2% vs 4%; S2 3% vs 2%; and S3 6% vs 4%. The most common adverse events (incidence ≥5%; all strata) were similar for SFC and FP and were: nasopharyngitis, upper RTI headache, sinusitis and influenza. There were no significant differences between treatments in 24-hour free urinary cortisol excretion at week 52 versus baseline. Conclusions Long-term treatment with salmeterol/fluticasone or fluticasone stepped-up to achieve Total Control is safe and well tolerated.