Data support new drug application by end of 2016
Positive results have been reported from a pivotal phase 3 study of an investigational once-daily closed triple combination therapy consisting of fluticasone furoate, umeclidinium, and vilanterol (FF/UMEC/VI, GlaxoSmithKline/Innoviva, Inc.)––a combination inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta agonist––in patients with chronic obstructive pulmonary disease (COPD).
The FULFIL (Lung FUnction and Quality of LiFe Assessment in COPD With Closed TrIpLe Therapy) trial was a randomized, double-blind, double-dummy, parallel-group multicenter study evaluating once-daily FF/UMEC/VI (100 mcg/62.5 mcg/25 mcg) inhalation powder compared with twice-daily budesonide/formoterol (400 mcg/12 mcg) (Symbicort, AstraZeneca), both delivered via the Turbohaler dry powder inhaler. A total of 1,810 patients were treated at 162 study centers globally (911 on FF/UMEC/VI and 899 on budesonide/formoterol).
The co-primary endpoints were the change from baseline in the trough forced expiratory volume in one second (FEV1) and in the St. George’s Respiratory Questionnaire (SGRQ) total score after 24 weeks of treatment. Other endpoints included the effect of FF/UMEC/VI on the annual rate of moderate-to-severe exacerbations compared with that of budesonide/formoterol and the safety profile of FF/UMEC/VI compared with that of budesonide/formoterol over 24 weeks and 52 weeks of treatment. To provide additional longer-term safety data, a subset of 430 patients continued to receive blinded study treatment for up to a total of 52 weeks.
The study met its coprimary endpoints, demonstrating statistically significant improvements compared with twice-daily Symbicort Turbohaler (budesonide/formoterol 400 mcg/12 mcg) in both lung function, as measured by the FEV1 (+171 mL; P < 0.001), and health-related quality of life, as measured by the SGRQ (–2.2 units; P < 0.001) at the end of the 24-week study period. Fifty percent of the patients receiving FF/UMEC/VI responded with the minimum clinically important difference in the SGRQ (–4 units) compared with 41% of those receiving budesonide/formoterol.
At 24 and 52 weeks, the most common adverse events across both treatment arms were nasopharyngitis, headache, and COPD worsening.
GSK intends to submit a new drug application for the closed triple combination therapy in COPD by the end of 2016.
Source: GlaxoSmithKline(link is external); June 20, 2016.
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