Long-term safety and efficacy of fluticasone/formoterol combination therapy in asthma.

BACKGROUND The long-term safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol; flutiform(®)) was assessed. METHOD In an open-label study, mild to moderate-severe asthmatics (≥12 years; N=472) were treated twice daily with fluticasone/formoterol 100/10 μg (n=224) or 250/10 μg (n=248) for 6 months (n=256) or 12 months (n=216). The primary and secondary objectives were the long-term safety and efficacy of fluticasone/formoterol, respectively. RESULTS In total, 413 (87.5%) patients completed the study (of which 175 participated for 12 months). Adverse events (AEs) were reported by 174 patients (36.9%): 67 (29.9%) in the 100/10 μg group and 107 (43.1%) in the 250/10 μg group. The most common AEs (>2%) were nasopharyngitis, dyspnea, pharyngitis, and headache; the majority were mild to moderate. Only 18 (3.8%) patients reported AEs considered study drug-related. Five patients per group experienced 12 serious AEs; none was study medication-related. Asthma exacerbations were reported by 53 patients (11.2%): 46 mild to moderate and nine severe. Clinical laboratory tests and vital signs showed no abnormal trends or clinically important or dose-response-related changes. The efficacy analyses showed statistically significant improvements at every time point throughout the study period at both doses. CONCLUSION Fluticasone/formoterol had a good safety and efficacy profile over the 6- and 12-month study periods.