Fluticasone propionate/formoterol fumarate: a review of its use in persistent asthma

The corticosteroid fluticasone propionate (fluticasone) and the long-acting β₂-adrenoceptor agonist formoterol fumarate (formoterol) have been combined in a single, pressurized, metered-dose, aerosol inhaler for the maintenance treatment of patients aged ≥12 years with persistent asthma. This article reviews the clinical efficacy and tolerability of fluticasone/formoterol, with a brief summary of pharmacodynamic and pharmacokinetic properties of the individual drugs. In well designed 8- and 12-week clinical trials in patients with asthma, twice-daily fluticasone/formoterol 100/10, 250/10 (adults and adolescents) or 500/20 μg (adults only) demonstrated rapid and sustained improvements in lung function and asthma control. Improvements achieved with the fixed combination were greater than those achieved with placebo or monotherapy with either of the same respective dosages of fluticasone or formoterol, and similar to those demonstrated when the individual components were administered via separate inhalers concurrently. The efficacy of fluticasone/formoterol was noninferior to that of fluticasone/salmeterol or budesonide/formoterol. Fluticasone/formoterol demonstrated a faster onset of bronchodilation than fluticasone/salmeterol. Fluticasone/formoterol was generally well tolerated, including during treatment periods of up to 12 months. The tolerability profile of fluticasone/formoterol was generally similar to that of fluticasone/salmeterol or budesonide/formoterol.