Pneumologie 2019; 73(S 01)
DOI: 10.1055/s-0039-1678331
Posterbegehung (P25) – Sektion Klinische Pneumologie
Klinische Studien zur COPD
Georg Thieme Verlag KG Stuttgart · New York

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

DA Lipson
1   Glaxosmithkline, Perelman School of Medicine, University of Pennsylvania
,
F Barnhart
2   Glaxosmithkline, Research Triangle Park
,
I Boucot
3   Glaxosmithkline, Global Respiratory Franchise
,
C Crim
2   Glaxosmithkline, Research Triangle Park
,
N Brealey
4   Glaxosmithkline, Stockley Park West
,
G Criner
5   Lewis Katz School of Medicine at Temple University
,
M Dransfield
6   Division of Pulmonary, Allergy, and Critical Care Medicine, Lung Health Center, University Alabama at Birmingham
,
DMG Halpin
7   Department of Respiratory Medicine, Royal Devon and Exeter Hospital
,
S Kilbride
4   Glaxosmithkline, Stockley Park West
,
MK Han
8   University of Michigan, Pulmonary and Critical Care
,
P Lange
9   University of Copenhagen
,
DA Lomas
10   Ucl Respiratory, University College London
,
FJ Martinez
11   New York-Presbyterian Hospital, Weill Cornell Medical Center
,
D Singh
12   Center of Respiratory Medicine and Allergy, Manchester Academic Health Science Center, University of Manchester, University Hospital of South Manchester, NHS Foundation Trust
,
I Naya
3   Glaxosmithkline, Global Respiratory Franchise
,
CE Jones
2   Glaxosmithkline, Research Triangle Park
,
R Wise
13   Division of Pulmonary, Allergy, and Critical Care Medicine, Johns Hopkins Medicine
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Publikationsverlauf

Publikationsdatum:
19. Februar 2019 (online)

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The abstract will be presented as an ENCORE by Dr. Sven Micklisch on behalf of the authors with their permissions. It was presented at ERS 2018 in Paris.

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 100/62.5/25 µg (FF/UMEC/VI), FF/VI 100/25 µg or UMEC/VI 62.5/25 µg, 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 1 s (trough FEV1), St Georgeʼs 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 40 mL and −3 mL, treatment difference 43 mL [95% CI: 28, 58 mL]; p < 0.001). The mean CFB in SGRQ Total score at week 52 was similar for both treatments (−3.7 units).

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.

Funding GSK (study CTT116855; NCT02164513).