June 23, 2016
Top-line results from a phase III study show improved lung function and health-related quality of life with a three-drug combination for chronic obstructive pulmonary disease (COPD) versus dual therapy with budesonide/formoterol.
The FULFIL (Lung Function and Quality of Life Assessment in COPD With Closed Triple Therapy) study was a randomized, double-blind, parallel-group, multicenter study evaluating once-daily fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100 mg/62.5 mg/ 25 mg inhalation powder versus twice-daily budesonide/formoterol 400 mg/12 mg in a total of 1810 patients (911 on FF/UMEC/VI and 899 on budesonide/formoterol). Primary endpoints were lung function, as measured by change from baseline in trough FEV1 (force expiratory volume in 1 second), and health-related quality of life, as measured by St George's Respiratory Questionnaire (SGRQ) total score after 24 weeks of treatment.
Long-term safety was also assessed in a subset of 430 patients who remained on blinded study treatment for up to a total of 52 weeks.
At the end of the 24-week study period, patients taking the combination treatment demonstrated statistically significant improvements in both trough FEV1 (171 mL; 95% CI, 148-194; P < .001) and SGRQ score (-2.2 units; 95% CI, -3.5 to -1.0; P < .001) compared with the comparator treatment.
After 24 weeks of treatment, rates of serious adverse events for FF/UMEC/VI and budesonide/formoterol were similar (5.4% vs 5.7%). The most common serious adverse events included worsening of COPD (1.3% vs 2.3%); pneumonia (1.0% vs 0.3%); and cardiac disorders (0.3% vs 1.0%).
Patients included in the 52-week extension reported higher rates of serious adverse events for FF/UMEC/VI and budesonide/formoterol (10.0% vs 12.7%), with the most common event being worsening of COPD (2.4% vs 9.1%), followed by pneumonia (1.9% vs. 1.8%) and cardiac disorders (1.4% vs. 0.9%).
Mike Aguiar, the CEO of Innoviva, Inc, stated, “With the FULFIL study,” GSK plans to submit a New Drug Application for the closed triple combination therapy in COPD to the FDA by the end of 2016. -Julie Gould
GlaxoSmithKline plc. FULFIL study shows superiority of closed triple combination therapy FF/UMEC/VI versus Symbicort® Turbohaler® in improving lung function and health-related quality of life in COPD patients [press release]. GSK Website. Published June 20, 2016. Accessed June 21, 2016.