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Exacerbation outcomes with LAMA/LABA and ICS/LABA in high risk COPD patients in the IMPACT trial

Rationale: Current GOLD strategy document positions both combination regimens of inhaled corticosteroid plus a long-acting β2-agonist [ICS/LABA] and LABA plus long-acting muscarinic antagonist [LAMA/LABA] for symptomatic patients with recurrent exacerbations (GOLD D) but only LAMA/LABA for persistently symptomatic patients with ≤ 1 non-hospitalized exacerbations (GOLD B). A recent study suggests superiority of LABA/LAMA over ICS/LABA (NEJM 2016;374:23) Methods: The InforMing the PAthway of COPD Treatment (IMPACT) study evaluated the annual rate of moderate/severe exacerbations on fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25μg vs. UMEC/VI (LAMA/LABA) 62.5/25μg and FF/VI (ICS/LABA) 100/25μg over 52-weeks in symptomatic patients with ≥1 exacerbation. This analysis compared annual rate and time to first (TTF) exacerbation between UMEC/VI and FF/VI in the intention-to-treat (ITT) population and within subgroups (some analyses were post-hoc). Findings: In the ITT analysis, FF/VI reduced exacerbation rate vs. UMEC/VI (p Conclusion: In IMPACT, exacerbation rate reduction favoured FF/VI vs. UMEC/VI in the ITT, GOLD D and baseline triple therapy-treated patients. In baseline LAMA-treated patients, and consistent with FLAME findings, there was a trend favouring UMEC/VI but low statistical power limited confirmation. Funding: GSK (NCT02164513)