GlaxoSmithKline plc announced results from the paediatric ‘LABA’ (long acting beta2-agonist) safety study. VESTRI (SAS115358) compared Advair® Diskus® (FSC), a combination of the LABA, salmeterol, and the inhaled corticosteroid (ICS), fluticasone propionate (FP), to FP monotherapy in children aged 4 – 11 years. The study assessed the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations).
The VESTRI study randomised 6,250 children aged 4 – 11 years into the six month study, across 31 countries. The primary safety endpoint of the study showed FSC twice-daily (100/50mcg, 250/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg), on the risk of serious asthma-related events, Hazard Ratio (HR) 1.285, (95% CI 0.726, 2.272) p=0.006. All serious asthma-related events were hospitalisations (n=48), and there were no asthma-related deaths or intubations seen in either arm of the study.
In the study a non-statistically significant reduction of 14% was observed in the risk of time-to-first asthma exacerbation for FSC compared to FP (HR 0.859; 95% CI 0.729, 1.012).
VESTRI is the second study undertaken by GSK as a post-marketing requirement of the US Food and Drug Administration (FDA). The first study, AUSTRI, carried out with adolescent and adult patients with asthma,demonstrated non-inferiority of FSC compared to FP and these data have been published in the New England Journal of Medicine1. GSK was one of four manufacturers of LABA-containing products indicated for the treatment of asthma, required to undertake equivalent studies designed to evaluate whether the addition of a LABA to an ICS increased the risk of an event in the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations) in adolescents and adults. GSK was the only manufacturer to conduct a study in children aged 4-11 years of age, as it is the only manufacturer with a licence to treat this age group in the US. The FSC 250/50mcg dose is not licensed for the treatment of paediatrics with asthma.
