IMPACT study of Trelegy Ellipta in COPD published in NEJM.- GlaxoSmithKline + Innoviva.

GlaxoSmithKline and Innoviva announced the publication in the New England Journal of Medicine (NEJM) of the landmark IMPACT study, one of the biggest ever conducted in patients using Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) with chronic obstructive pulmonary disease (COPD) with a history of exacerbation. In the study, Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol, �FF/UMEC/VI� 100/62.5/25mcg) achieved superiority to members of two different classes of dual combination therapy, Relvar/Breo (FF/VI) and Anoro (UMEC/VI), on the primary endpoint of reduction in the annual rate of on-treatment moderate/severe exacerbations and a range of other clinically important outcomes, including lung function and health-related quality of life.

The data shows a statistically significant 34% reduction in COPD hospitalisations (severe exacerbations) for Trelegy compared to Anoro (0.13 vs. 0.19 per year; p<0.001) and a reduction of 13% compared to relvar breo which was not statistically significant (0.13 vs. 0.15; p="0.064)." it also demonstrates a significant reduction in the risk of on-treatment all-cause mortality was observed for both inhaled corticosteroid containing arms compared to anoro. in addition, it shows a 42.1% reduction in the risk of on-treatment all-cause mortality was observed for trelegy compared to anoro (1.20% vs. 1.88%; p="0.011)." the safety profile of single inhaler triple therapy was consistent with the safety profile of the individual components. the most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of copd, upper respiratory tract infection, pneumonia and headache.>

See: "Once-Daily Single Inhaler Triple Versus Dual Therapy in Patients with COPD." Lipson DA et al. New England Journal of Medicine. April 2018.