Comparison of LAMA/LABA vs. ICS/LABA in high risk COPD patients: Pre-specified analysis on lung function and health status from the IMPACT trial

Abstract

Rationale: Current GOLD strategy document positions both combination regimens of inhaled corticosteroid plus a long-acting β2-agonist [i.e. ICS/LABA] and long-acting muscarinic antagonist plus LABA [i.e. LAMA/LABA] for symptomatic patients with recurrent exacerbations. Methods: The InforMing the PAthway of COPD Treatment (IMPACT) study was a phase III, double-blind, parallel-group, multicenter study that compared the efficacy and safety of single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol 100/62.5/25µg (FF/UMEC/VI), FF/VI 100/25µg or UMEC/VI 62.5/25µg, all using the ELLIPTA® inhaler in symptomatic patients with COPD and exacerbation history, randomised 2:2:1, respectively to 52 weeks of treatment. The primary efficacy results on the annual rate of moderate or severe exacerbations are presented separately. Additional endpoints included change from baseline [CFB] in forced expiratory volume in 1s (trough FEV1), St George’s Respiratory Questionnaire (SGRQ) for FF/VI compared with UMEC/VI. Results: Of the 10 355 patients enrolled, 4134 received FF/VI and 2070 received UMEC/VI. At Week 52, there was a statistically significant improvement in trough FEV1 with UMEC/VI vs FF/VI (mean CFB 40mL and –3mL, treatment difference 43mL [95% CI: 28, 58mL]; p Conclusions: UMEC/VI improved lung function compared with the once daily ICS/LABA FF/VI in patients with symptomatic COPD and at risk of exacerbations whereas the SGRQ Total score was similar. These results may help to inform treatment choices for this patient population.