Safety and efficacy of long-term treatment with fluticasone propionate and salmeterol via DISKUS versus fluticasone propionate alone

This 52 week study (ADA109057; ClinicalTrials.gov identifier: NCT00452348) was designed to assess the safety and efficacy of fluticasone propionate (FP)/salmeterol 250/50 mcg via DISKUS (FSC) vs FP 250 mcg in subjects with persistent asthma symptomatic on FP 100 mcg. The objective was to demonstrate superiority in lung function (FEV1) of FSC 250/50 mcg vs FP 250 mcg. Secondary objectives included AM PEF, percentage of symptom-free days, and rate of asthma attacks. Three hundred and ten subjects received FSC 250/50 mcg and 318 subjects received FP 250 mcg, both administered twice daily following a 14–21 days of open-label FP 100 mcg. Treatment with FSC 250/50 mcg resulted in an improvement in lung function vs FP 250 mcg (p = 0.09). Additionally, treatment with FSC 250/50 mcg improved AM PEF and increased the percentage of symptom-free days. The asthma attack rate was similar between treatments, as was the safety profile. FSC 250/50 mcg demonstrated improvements in lung function and asthma control vs FP 250 mcg, although statistically significant differences were not consistent. The differences may be representative of this population with less severe disease at entry. In patients with mild-to-moderate persistent asthma FSC offers improved parameters of asthma control compared with ICS alone.