Abstract
Background: IMPACT is a randomized, multicenter study (52 weeks) comparing the efficacy and safety of fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) vs FF/VI and UMEC/VI in patients ≥40 years of age with symptomatic COPD and a history of exacerbations (exac) (N=10,355). For the primary endpoint, FF/UMEC/VI demonstrated a significant reduction in moderate (mod)/severe (sev) exac vs FF/VI and UMEC/VI (NEJM 2018;378:18).
Objectives: Evaluate the overall benefit of FF/UMEC/VI by assessing outcomes across other COPD endpoints over time.
Methods: Pre-specified endpoints were trough FEV1 (weeks 4, 16, 28, 40, 52) and SGRQ, TDI and CAT (weeks 4, 28, 52) analyzed by mixed models repeated measures.
Results: FF/UMEC/VI vs FF/VI and UMEC/VI showed significant improvement in trough FEV1 (Figure) and SGRQ at week 4 that continued throughout the trial at all measured timepoints. FF/UMEC/VI demonstrated significant improvements in CAT vs FF/VI at all timepoints, and at weeks 4 and 52 compared to UMEC/VI.
Conclusions: FF/UMEC/VI showed significant benefit across a range of COPD endpoints over time vs FF/VI and UMEC/VI. This underscores the consistent efficacy profile of FF/UMEC/VI and supports its role in the treatment of symptomatic patients with a history of exacerbations.
Funding: GSK (Study CTT116855; NCT02164513).
Footnotes
Cite this article as: European Respiratory Journal 2019; 54: Suppl. 63, PA2482.
This is an ERS International Congress abstract. No full-text version is available. Further material to accompany this abstract may be available at www.ers-education.org (ERS member access only).
- Copyright ©the authors 2019
