2 research outputs found
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 b2-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®; 250/10 mg) administered twice
daily (b.i.d.) via a single aerosol inhaler, with the individual components (fluticasone 250 mg
b.i.d.; formoterol 10 mg 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, placebocontrolled 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 mg 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 mg vs. fluticasone), and iii) the number of patients who discontinued prematurely due
to lack of treatment efficacy (fluticasone/formoterol 250/10 mg 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 mg
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