Abstract
BackgroundThis study investigated the efficacy and safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol; flutiform®), administered twice daily (b.i.d.) via a single aerosol inhaler, compared with its individual components administered separately and placebo, in patients with mild-to-moderate asthma.MethodsPatients aged ≥ 12 years were evenly randomised to 12 weeks of treatment with fluticasone/formoterol (100/10 μg b.i.d.), fluticasone (100 μg b.i.d.), formoterol (10 μg b.i.d.), or placebo, in this double-blind, parallel group, multicentre study. The three co-primary endpoints were: a) change in forced expiratory volume in the first second (FEV1) from morning pre-dose at baseline to pre-dose at week 12 for the comparison with formoterol; b) change in FEV1 from morning pre-dose at baseline to 2 hours post-dose at week 12 for the comparison with fluticasone, and c) time to discontinuation due to lack of efficacy from baseline to week 12 for the comparison with placebo. Safety was assessed based on adverse events, clinical laboratory tests and vital sign evaluations.ResultsStatistically significant differences were demonstrated for all the three co-primary endpoints. Fluticasone/formoterol combination therapy showed significantly greater improvements from baseline to end of study in the change in pre-dose FEV1 compared with formoterol (Least Squares (LS) mean treatment difference: 0.101 L; 95% Confidence Interval (CI): 0.002, 0.199; p = 0.045) and the change in pre-dose compared with 2 hours post-dose FEV1 versus fluticasone (LS mean treatment difference: 0.200 L; 95% CI: 0.109, 0.292; p < 0.001). The time to discontinuation due to lack of efficacy was significantly longer for patients in the combination therapy group compared with those receiving placebo (p = 0.015). Overall, the results from multiple secondary endpoints assessing lung function, asthma symptoms, and rescue medication use supported the superior efficacy of the combination product compared with fluticasone, formoterol, and placebo. The fluticasone/formoterol combination therapy had a good safety and tolerability profile over the 12 week treatment period.ConclusionsFluticasone/formoterol had a good safety and tolerability profile and showed statistically superior efficacy for the three co-primary endpoints compared to fluticasone, formoterol, and placebo, in adolescents and adults with mild-to-moderate asthma.EudraCT number: 2007-002866-36; US NCT number: NCT00393991
Highlights
This study investigated the efficacy and safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate, administered twice daily (b.i.d.) via a single aerosol inhaler, compared with its individual components administered separately and placebo, in patients with mild-to-moderate asthma
Landmark studies in adult and adolescents have demonstrated that patients using inhaled corticosteroids (ICSs) and long-acting β2-agonist (LABA) combination therapy achieved better asthma control compared to more than doubling the dose of ICS or administration of ICS in combination with other therapeutic agents [2,4,5,6,7,8,9,10,11,12], while further studies in children and adolescents aged up to 16 years have reported at least similar efficacy with ICS/LABA compared with doubling the ICS dose [13,14]
Treatment groups were well-matched with regard to demographics and baseline characteristics, with little difference between groups with respect to lung function reversibility
Summary
This study investigated the efficacy and safety of a new asthma therapy combining fluticasone propionate and formoterol fumarate (fluticasone/formoterol; flutiformW), administered twice daily (b.i.d.) via a single aerosol inhaler, compared with its individual components administered separately and placebo, in patients with mild-to-moderate asthma. Asthma is a chronic inflammatory disorder of the airways. It is associated with variable airflow obstruction related to airway hyperresponsiveness and bronchoconstriction. For persistent asthma, inhaled corticosteroids (ICSs) are recommended as one of the most effective treatments for airway inflammation. Landmark studies in adult and adolescents have demonstrated that patients using ICS and long-acting β2-agonist (LABA) combination therapy achieved better asthma control compared to more than doubling the dose of ICS or administration of ICS in combination with other therapeutic agents [2,4,5,6,7,8,9,10,11,12], while further studies in children and adolescents aged up to 16 years have reported at least similar efficacy with ICS/LABA compared with doubling the ICS dose [13,14]. Research has shown that the interactions between ICSs and LABAs potentiate each other’s respective therapeutic effects at the molecular level [15,16,17,18]
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