GSK’s Advair Diskus asthma drug achieves primary endpoint in study

The primary endpoint of the study demonstrated that the Advair Diskus-combination (FSC) twice-daily showed non-inferiority compared to corresponding doses of fluticasone propionate (FP) twice-daily on the risk of serious asthma-related events.

GSK said all severe asthma-related events were hospitalizations, and there were no asthma-associated deaths or intubations seen in either arm of 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.

Under the six-month Vestri study, 6,250 children aged 4 to 11 years were randomized across 31 countries.

GSK claims that it was the only manufacturer to carry out a study in children aged 4-11 years of age and is the only manufacturer with a licence to treat this age group in the US.

It is the second study undertaken by GSK as a post-marketing requirement of the US Food and Drug Administration (FDA).

The initial study, Austri, undertaken with adolescent and adult patients with asthma,demonstrated non-inferiority of FSC compared to FP.

Long-acting beta2-adrenergic agonists (LABA), like salmeterol, one of the active ingredients in Advair Diskus, increase the risk of asthma-related death.

Available data from controlled clinical trials indicate that LABA increase the risk of asthma-related hospitalization in pediatric and adolescent patients.

Advair Diskus is not indicated for the relief of acute bronchospasm.