Abstract
BackgroundCurrent maintenance therapies for asthma require twice-daily dosing. Vilanterol (VI) is a novel long-acting beta2 agonist, under development in combination with fluticasone furoate, a new inhaled corticosteroid (ICS). Findings from a previous 4-week study suggested that VI has inherent 24-hour activity and is therefore suitable for once-daily dosing. The study described here was a double-blind, double-dummy, randomised, placebo-controlled trial, the aim of which was to assess the efficacy of once-daily VI compared with placebo in patients with persistent asthma. The primary endpoint was change from baseline in 24-hour weighted mean forced expiratory volume in 1 second after 12 weeks of treatment vs. placebo. An active control arm received salmeterol (SAL) twice daily. All patients were maintained on a stable background dose of ICS.ResultsPatients (n = 347) received VI, placebo or SAL (1:1:1). For the primary endpoint, substantial improvements in lung function were seen with VI (359 ml), SAL (283 ml) and placebo (289 ml). There were no statistically significant treatment differences between either the VI (70 ml, P = 0.244) or SAL (-6 ml, P = 0.926) groups and placebo. Both active treatments were well tolerated, with similarly low rates of treatment-related adverse events compared with placebo. No treatment-related serious adverse events occurred.ConclusionsThis study failed to show a treatment difference between VI and placebo for the primary endpoint, in the presence of a placebo response of unforeseen magnitude. Because the placebo response was so large, it is not possible to draw meaningful conclusions from the data. The reason for this magnitude of effect is unclear but it may reflect increased compliance with the anti-inflammatory therapy regimen during the treatment period.Trial registrationNCT01181895 at ClinicalTrials.gov.
Highlights
Current maintenance therapies for asthma require twice-daily dosing
Data describing demography, baseline lung function (FEV1), reversibility and rescue medication use are provided in Table 1 and, excepting the latter, are presented by country
Neither VI nor SAL were significantly superior to placebo on the primary endpoint; a change from baseline of −6 ml compared with placebo was observed in the SAL group
Summary
Current maintenance therapies for asthma require twice-daily dosing. Vilanterol (VI) is a novel longacting beta agonist, under development in combination with fluticasone furoate, a new inhaled corticosteroid (ICS). Findings from a previous 4-week study suggested that VI has inherent 24-hour activity and is suitable for once-daily dosing. Asthma is a chronic inflammatory disease characterised by airway hyper-responsiveness which causes narrowing of airways and obstruction of air flow. This typically occurs following exposure to a stimulus such as an allergen or chemical and is associated with inflammation of the airway [1]. This produces symptoms including dyspnoea (shortness of breath), wheezing and cough that generally resolve in response to treatment and/or removal of the triggering stimulus [2]. The forced expiratory volume in one second (FEV1) measurement has been validated for its close correlation with airway obstruction and is predictive for the presence of asthma and asthma mortality [5]
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