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# GSK, Innoviva Report Positive Data on COPD Drug Combo
- URL: https://www.fdaweb.com/gsk-innoviva-report-positive-data-on-copd-drug-combo/
- Published: 2016-09-07T12:00:00.000Z
- Updated: 2026-09-14T21:30:07.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136719

GlaxoSmithKline and Innoviva have released positive data from the pivotal Phase 3 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). The 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.

The study, [which reported headline results in June](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.gsk.com%2Fen-gb%2Fmedia%2Fpress-releases%2F2016%2Ffulfil-study-shows-superiority-of-closed-triple-combination-therapy-ffumecvi-versus-symbicort-turbohaler-in-improving-lung-function-and-health-related-quality-of-life-in-copd-patients%2F&esheet=51413501&newsitemid=20160906005414&lan=en-US&anchor=which+reported+headline+results+in+June+2016&index=1&md5=2eb7f46cf468f9f22c097e723051472f&ref=fdaweb.com), met its two co-primary endpoints. “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 FEV1 (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...,” the companies say. “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).” Treatment benefit with the closed triple therapy was also observed in a subset of patients who received treatment for up to 52 weeks, they add.

  
The safety profile of the closed triple combination up to 24 weeks and in the subset of patients up to 52 weeks was consistent with the known profile of the individual medicines and their combinations, the companies say. Up to both 24 weeks and 52 weeks, the most common adverse events in both treatment arms were nasopharyngitis, headache and COPD worsening.