This benefit of treatment with closed triple therapy was also observed in the subset of patients who received treatment for up to 52 weeks, with a statistically significant improvement of 179mL in trough FEV 1 and a numerical improvement of -2.7 units in SGRQ total score at Week 52 with closed triple therapy compared with budesonide/formoterol. In addition, the proportion of patients who responded with the minimum clinically important difference in SGRQ (-4 units) was 50% on closed triple and 41% on budesonide/formoterol (odds ratio 1.41 p<0.001). At 24 weeks, there was a clinically meaningful and statistically significant (p<0.001) benefit for FF/UMEC/VI in both lung function, measured as mean change from baseline in trough FEV 1 (171mL, 95% confidence interval ) and health-related quality of life, measured as mean change from baseline in St George’s Respiratory Questionnaire (SGRQ) total score (-6.6 units for closed triple versus -4.3 units for budesonide/formoterol, difference of -2.2 units, 95% confidence interval ). The study, which reported headline results in June 2016, met its two co-primary endpoints. The FULFIL study was designed to evaluate the effects of once daily FF/UMEC/VI compared with twice daily Symbicort ® Turbohaler ® (budesonide/formoterol 400/12 mcg) in patients with advanced COPD.
(NASDAQ: INVA) today announced the presentation of further data from the pivotal phase III FULFIL study with investigational closed triple combination therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI 100/62.5/25 mcg) in patients with chronic obstructive pulmonary disease (COPD), at the European Respiratory Society International Congress taking place in London this week. GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc.
Improvements in lung function and health-related quality of life supported by statistically significant reductions in exacerbations.
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