Research in context
Evidence before this study
We searched PubMed for articles published before Sept 13, 2016, with no start date or language restrictions, using the search terms “Drug Therapy, Combination” [MeSH Terms] OR “triple” AND “COPD” AND “trial”, with no limits applied. Of the 524 results, 18 studies presented data from clinical trials evaluating the efficacy of triple therapy with an inhaled corticosteroid plus a long-acting β2-agonist plus a long-acting muscarinic antagonist, with one retrospective cohort analysis. Of these, six studies compared triple therapy with a long-acting muscarinic antagonist therapy; and five compared triple therapy with both a long-acting muscarinic antagonist and an inhaled corticosteroid plus a long-acting β2-agonist. Although most studies were of short duration (mostly 12–24 weeks), a number showed a reduction in the rate of exacerbations for triple therapy versus long-acting muscarinic antagonist, together with a consistent improvement in bronchodilation. However, results were more variable for the other endpoints, including health-related quality of life, and none of these studies used a single inhaler triple combination.
Added value of this study
To our knowledge, this is the first long-term study specifically designed to evaluate the effect of a single inhaler triple therapy versus long-acting muscarinic antagonist therapy on the rate of exacerbations in a population at high exacerbation risk.
Implications of all the available evidence
By comparison with long-acting muscarinic antagonist alone, 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 this high-risk population, together with improvements in lung function, and in a range of other clinically relevant measures.