GlaxoSmithKline has announced results from the pediatric LABA safety study, VESTRI, which compared Advair Diskus (a combination of the LABA, salmeterol, and the inhaled corticosteroid fluticasone propionate), to FP monotherapy in children aged 4-11 years. The study assessed the composite endpoint of serious asthma-related events (deaths, intubations or hospitalizations).
The VESTRI study randomized 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 hospitalizations (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 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 Medicine.
The VESTRI study was a global, multicenter, randomized stratified, double-blind, parallel-group active comparator, six-month study in pediatric patients (4-11 years of age) with asthma. Patients were screened at visit one to assess eligibility and subsequently randomized 1:1 to either FSC (100/50 mcg, 250/50 mcg) or FP (100mcg, 250 mcg) at visit two.
The primary analysis was to determine whether the addition of LABA to ICS therapy (FSC) is non-inferior to ICS therapy alone (FP) in terms of the risk of a composite of serious asthma-related events (asthma-related hospitalization, intubation and death). To demonstrate non-inferiority, a predefined margin of 2.675 was required, meaning the upper limit of the 95% confidence interval needed to be less than 2.675 to rule out an increase in the risk of a serious asthma related event on FSC compared with FP. All serious asthma related events were adjudicated by an independent committee.