Scientists at GlaxoSmithKline (GSK) recently released the results from their study for a pediatric long acting beta2-agonist (LABA) safety trial, which compared Advair Diskus (FSC) to FP monotherapy treatments for children between the ages of four and 11 years old.
Advair Diskus combines salmeterol, LABA, fluticasone propionate (FP) and the inhaled corticosteroid (ICS).
The purpose of the study, called VESTRI, was to determine the composite endpoint for serious asthma-related events, like intubations, deaths and hospitalizations. This is the second study from GSK. Leaders at the U.S. Food and Drug Administration (FDA) require that this study be conducted for post-marketing.
The study involved 6,250 children between the ages of four and 11 years old, which were enrolled in a six-month long study that covered 31 countries. The endpoint suggests that FSC twice-daily is a non-inferiority for the risk of serious asthma-related events when compared to corresponding FP twice-daily doses.
The study, available in the New England Journal of Medicine, showed a non-statistically significant decrease amounting to 14 percent for the risk of time-to-first asthma exacerbation involving FSC over FP.
The first study of this kind was called AUSTRI and involved adolescents and adults who have asthma. This study also showed non-inferiority when FSC was compared to the traditional FP therapies.