Efficacy and safety of fluticasone/formoterol combination therapy in patients with moderate-to-severe asthma

Abstract

The inhaled corticosteroid, fluticasone propionate, and the long-acting β(2)-adrenergic agonist, formoterol fumarate, are both highly effective treatments for bronchial asthma. This study (NCT00393952/EudraCT number: 2006-005989-39) compared the efficacy and safety of fluticasone/formoterol combination therapy (flutiform(®); 250/10μg) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250μg b.i.d.; formoterol 10μg b.i.d.), in adult and adolescent patients with moderate-to-severe asthma. This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebocontrolled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV(1)) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10μg vs. formoterol), ii) the mean change in FEV(1) from morning pre-dose at baseline to 2h post-dose at week 12 (fluticasone/formoterol 250/10μg vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10μg vs. placebo). The secondary endpoints included measures of lung function, disease control, and asthma symptoms. Safety was assessed based on adverse events, vital signs, and clinical laboratory evaluations. Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10μg b.i.d. was superior to the individual components and placebo for all three co-primary endpoints and demonstrated numerically greater improvements for multiple secondary efficacy analyses. Fluticasone/formoterol combination therapy had a good safety profile over the 12 weeks. Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma.