Efficacy and safety of fluticasone and formoterol in a single pressurized metered dose inhaler

Background: Fluticasone and formoterol are well established medications for the treatment of asthma. This study (Clinicaltrials.gov identifier: NCT00734318) compares the efficacy and safety of a combination of these drugs in a single inhaler (fluticasone/formoterol) versus the individual components (fluticasone + formoterol). Methods: Patients aged >= 18 years (n = 620) with a history of severe, persistent reversible asthma for >= 6 months prior to screening were included in this randomized, double-blind study, which consisted of a screening phase of up to 5 days, a 2-week run-in phase and an 8-week treatment period. Results: Fluticasone/formoterol (500/20 mu g, b.i.d.) was at least as effective as fluticasone + formoterol (500 mu g + 24 mu g, b.i.d.) with respect to the primary outcome measure: there were similar increases in mean pre-morning dose forced expiratory volume in the first second (FEV1) in these two groups. Fluticasone/formoterol (500/20 mu g, b.i.d.) also demonstrated similar efficacy to fiuticasone + formoterol in terms of change in mean FEV1 from baseline pre-morning dose to 2 h post-morning dose at week 8, as well as for several secondary parameters. Fluticasone/formoterol (500/20 mu g, b.i.d.) demonstrated superiority to fluticasone monotherapy (500 mu g, b.i.d.) and fluticasone/formoterol (100/10 mu g, b.i.d.) for several secondary efficacy parameters. Fluticasone/formoterol had a similar safety and tolerability profile to fluticasone + formoterol. Conclusion: This study demonstrated that the fluticasone/formoterol combination is at least as effective as its components administered concurrently from separate inhalers. Fluticasone/formoterol (500/20 mu g, b.i.d.) showed superior efficacy to its inhaled corticosteroid component alone and the efficacy of fluticasone/formoterol was dose-dependent for several clinically important parameters. (C) 2010 Elsevier Ltd. All rights reserved.