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NEJM publishes results of GSK’s long-term LABA safety study of Advair Diskus in children aged 4-11 years with asthma

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Additional Relevant Details Headline results reported in March, demonstrated that the study had achieved its primary endpoint. The study compared Advair® Diskus®, a combination of the LABA, salmeterol and inhaled corticosteroid (ICS), fluticasone propionate (FP) to FP monotherapy, to assess the safety profiles of each medicine when used to treat children 4-11 years of age with asthma. This was assessed by the composite endpoint of serious asthma-related events (deaths, intubations or hospitalisations). These results are also being presented at the European Respiratory Society (ERS) International Congress in London, UK on 7th September, (Abstract number: OA4798).The primary endpoint of the study showed the salmeterol/FP combination (FSC) twice-daily (100/50mcg, 250/50mcg) demonstrated non-inferiority compared to corresponding doses of FP twice-daily (100mcg, 250mcg), Hazard Ratio (HR) 1.285, (95% CI 0.726, 2.272) p=0.006 on the risk of serious asthma-related events. 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).
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Occurred on:
Sep 01, 2016
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Related Keywords Advair Diskus, Asthma, Laba Safety Study, Long Acting Beta2-agonist, Vestri, New England Journal Of Medicine, Fluticasone Propionate, Inhaled Corticosteroid, Salmeterol