TRIPLE THERAPY IN COPD: REVIEW OF CLINICAL TRIALS

Abstract

Recently, two “fixed triple” single-inhaler combinations of an inhaled corticosteroid (ICS), a long-acting β2-agonist (LABA), and a long-actingmuscarinic antagonist (LAMA) have become available for patientswith chronic obstructive pulmonary disease (COPD). This review provides evidence from clinical trials on the efficacy and safety of triple therapy. Of the fivemain fixed triple studies completed so far, three (TRILOGY, TRINITY and TRIBUTE) evaluated the efficacy and safety of an extra-fine formulation of beclometasone dipropionate, formoterol fumarate, and glycopyrronium; the other two studies (FULFIL and IMPACT) evaluated fluticasone furoate, vilanterol, and umeclidinium. Results of all clinical trials showed that triple therapy decreased the risk of exacerbations and improved lung function and health status, with a favourable benefit-to-harm ratio. The evidence suggests that triple therapy is themost effective treatment in symptomatic patientswith COPD at risk of exacerbations, with marginal if any risk of side effects. Furthermore, triple therapy showed a promising signal in terms of improved survival. Ongoing studies are examining the role of triple therapy in less severe symptomatic patients with COPD.