Research in context
Evidence before this study
We searched PubMed for articles published before Jan 4, 2018, using the search term “Drug Therapy, Combination”[MeSH Terms] OR triple AND COPD AND trial, with no limits applied. Of the 565 search results, 30 presented data from clinical trials investigating the efficacy of triple therapy consisting of an inhaled corticosteroid plus a long-acting β2-agonist plus a long-acting muscarinic antagonist. Only two of these studies included a group receiving a long-acting β2-agonist plus a long-acting muscarinic antagonist. One study compared the efficacy of triple therapy or dual bronchodilation with that of long-acting muscarinic antagonist monotherapy; although there were no formal statistical comparisons between triple therapy and dual bronchodilation, compared with patients receiving dual bronchodilation fewer patients receiving triple therapy had an exacerbation during the 1 year follow-up. The second study recruited patients who were newly diagnosed with COPD following referral for a surgical intervention for lung cancer, and who were then randomised to 1 week of treatment with triple therapy or dual bronchodilation.
Added value of this study
TRIBUTE is, to our knowledge, the first long-term study to specifically compare the effects of triple therapy in a single inhaler with those of dual bronchodilation on the rate of exacerbations.
Implications of all the available evidence
Compared with dual bronchodilator therapy, triple therapy with an inhaled corticosteroid, a long-acting β2-agonist, and a long-acting muscarinic antagonist in a single inhaler reduces the rate of COPD exacerbations in patients with symptomatic COPD, an FEV1 of less than 50%, and an exacerbation history, despite maintenance therapy.