GSK's Advair Diskus proves non-inferior in paediatric safety study

17th Mar 2016 07:39

(ShareCast News) - A study to determine the safety GlaxoSmithKline's combined asthma treatment in children has hit its primary end point.Monitoring the effects on 6,250 children aged 4-11 found GSK's Advair Diskus, a combination of the long acting beta2-agonist (LABA), salmeterol and inhaled corticosteroid fluticasone propionate (FP), demonstrated 'non-inferiority' compared to single-drug treatment fluticasone propionate (FP)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.Glaxo was required by the US Food and Drug Administration (FDA) to carry out the study, along with four other manufacturers of LABA-containing products, as a post-marketing requirement.The UK company, whose chief executive Andrew Witty announced his retirement on Thursday, 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.