Fluticasone propionate/formoterol fumarate combination therapy has comparable efficacy to its individual components administered concurrently

Background: A 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 the combination compared to its individual components administered concurrently (FLUT+FORM). Methods: Patients aged 12 years or over (N=210) with mild to moderate-severe persistent, reversible asthma were randomized in a 1:1 ratio to 12 weeks of twice daily treatment with one of two doses of FLUT/FORM or FLUT+FORM in an open-label, parallel group, multicentre study in Europe. Total daily doses were FLUT/FORM: 200/20μg or 500/20μg; FLUT+FORM: 200/24μg or 500/24μg. The primary objective was to show non-inferiority of FLUT/FORM compared to FLUT+FORM based on post-dose forced expiratory volume in 1 second (FEV1) on Day 84. Results: FLUT/FORM had comparable efficacy to FLUT+FORM in the treatment of asthma with mean FEV1 30 to 60 minutes post-dose on Day 84 of 2.6L in both groups (per protocol groups; least squares mean difference: -0.03 L; 95%CI: -0.148, 0.081; p=0.004). The lower limit of the 95% CI was above the pre-defined non-inferiority threshold of ≥-0.2L. Analysis of other pulmonary function tests, patient reported outcomes, rescue medication use, asthma exacerbations and quality of life questionnaires were also comparable. The safety profiles of the two study groups were similar overall. Conclusions: Fluticasone/formoterol combination therapy has comparable efficacy to its individual components administered concurrently. The safety and tolerability profile of fluticasone/formoterol combination therapy is similar to that of its individual components.