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

Background: The inhaled corticosteroid, fluticasone propionate, and the long-acting beta(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 fiuticasone/formoterol combination therapy (flutiform(R); 250/10 mu g) administered twice daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 mu g b.i.d.; formoterol 10 jig b.i.d.), in adult and adolescent patients with moderate-to-severe asthma. Methods: This was a 12-week, double-blind, randomised, parallel-group, multicentre, placebo-controlled phase 3 study. The co-primary efficacy endpoints were: i) the mean change in the forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 (fluticasone/formoterol 250/10 mu g vs. formoterol), ii) the mean change in FEV1 from morning pre-dose at baseline to 2 h post-dose at week 12 (fluticasone/formoterol 250/10 mu g vs. fluticasone), and iii) the number of patients who discontinued prematurely due to lack of treatment efficacy (fluticasone/formoterol 250/10 mu ig 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. Results: Overall, 395 (70.9%) patients completed the study. Fluticasone/formoterol 250/10 mu g 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. Conclusion: Fluticasone/formoterol combination therapy will provide clinicians with an efficacious alternative treatment option for patients with moderate-to-severe asthma. (C) 2012 Published by Elsevier Ltd.