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

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.