Fluticasone propionate/formoterol fumarate combination therapy has superior efficacy to both fluticasone and formoterol alone

Background: A new combination of fluticasone propionate and formoterol fumarate (FLUT/FORM; flutiform ®) in a single aerosol inhaler has been developed. This study investigated the efficacy and safety of a low dose of FLUT/FORM compared with its individual components administered alone. Methods: Patients aged 12 years or older (N=357) with mild to moderate asthma were evenly randomized to 12 weeks twice daily treatment with FLUT/FORM (100/10 μg b.i.d.) in a single inhaler, fluticasone (FLUT; 100 μg b.i.d.) or formoterol (FORM; 10 μg b.i.d.) in a double-blind, parallel group, multicentre study. The co-primary endpoints were the change in forced expiratory volume in the 1st second (FEV 1 ) from morning pre-dose at baseline to pre-dose at Week 12 compared with FORM and the change in FEV 1 from morning pre-dose at baseline to 2 hours post-dose at Week 12 compared with FLUT. Results: Statistically significant differences in the co-primary endpoints were recorded for FLUT/FORM compared with FLUT and FORM. FLUT/FORM showed significantly greater improvements in change in pre-dose FEV 1 compared with FORM (full analysis set; least squares (LS) mean difference: 0.118 L; 95% Confidence Interval (CI): 0.034, 0.201; p=0.006) and post-dose FEV 1 compared with FLUT (LS mean difference: 0.122 L; 95% CI: 0.040, 0.204; p=0.004). Sensitivity analyses supported the co-primary analyses. The safety profiles of FLUT/FORM and its components were comparable. Conclusions: Fluticasone/formoterol was safe and showed statistically superior efficacy for the co-primary endpoints compared to FLUT and FORM administered alone in adolescents and adults with mild to moderate asthma.