Single-Inhaler Triple Therapy and Health-Related Quality of Life in COPD: The IMPACT Study

Maggie Tabberer, C Elaine Jones, Sally Kilbride, David M G Halpin, David A Lomas, Steven Pascoe, Dave Singh, Robert A Wise, Gerard J Criner, Peter Lange, Mark T Dransfield, MeiLan K Han, Fernando J Martinez, Morrys C Kaisermann, David A Lipson, Maggie Tabberer, C Elaine Jones, Sally Kilbride, David M G Halpin, David A Lomas, Steven Pascoe, Dave Singh, Robert A Wise, Gerard J Criner, Peter Lange, Mark T Dransfield, MeiLan K Han, Fernando J Martinez, Morrys C Kaisermann, David A Lipson

Abstract

Introduction: The phase 3 InforMing the PAthway of COPD (chronic obstructive pulmonary disease) Treatment (IMPACT) trial, single-inhaler therapy with fluticasone furoate (FF) 100 μg, umeclidinium (UMEC) 62.5 μg, and vilanterol (VI) 25 μg demonstrated a reduction in the rate of moderate or severe exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic COPD at risk of exacerbations. This article reports additional evidence of improvements in symptoms and health-related quality of life (HRQoL) with FF/UMEC/VI compared with either FF/VI or UMEC/VI from the IMPACT study.

Methods: Patient-reported HRQoL assessments and symptom measures included as pre-specified IMPACT end points were the St George's Respiratory Questionnaire (SGRQ), COPD Assessment Test (CAT), and Baseline Dyspnea Index (BDI) as the anchor for the Transitional Dyspnea Index (TDI) focal score (BDI/TDI) in a subset of patients enrolled at study sites in North America and Europe. Change from baseline was assessed at weeks 4, 28, and 52.

Results: The intent-to-treat population included 10,355 patients (TDI population: 5058 patients). Clinically meaningful improvements in SGRQ total score between baseline and week 52 favored FF/UMEC/VI over FF/VI (- 1.8 units, p < 0.001) and UMEC/VI (- 1.8 units, p < 0.001). Similar improvements in the CAT and TDI focal score were also observed with FF/UMEC/VI versus FF/VI or UMEC/VI.

Conclusions: This study demonstrates that in patients with symptomatic COPD at risk of exacerbations, once-daily FF/UMEC/VI, compared with FF/VI or UMEC/VI, improves patient-perceived HRQoL and symptoms.

Trial registration number: NCT02164513.

Keywords: COPD; Exacerbations; Health-related quality of life; IMPACT trial; Patient-reported outcomes; Single-inhaler triple therapy.

Figures

Fig. 1
Fig. 1
a LS mean change (95% CI) from baseline in SGRQ total score; b mean change from baseline in SGRQ domain scores over 52 weeks (ITT population). *p < 0.001 for FF/UMEC/VI compared with FF/VI or UMEC/VI. CI confidence interval, FF fluticasone furoate, ITT intent to treat, LS least squares, SGRQ St George’s Respiratory Questionnaire, UMEC umeclidinium, VI vilanterol
Fig. 2
Fig. 2
LS mean change (95% CI) from baseline in CAT score over 52 weeks (ITT population). *p < 0.001 for FF/UMEC/VI compared with FF/VI or UMEC/VI; **p = 0.021 for FF/UMEC/VI compared with UMEC/VI. CAT COPD (chronic obstructive pulmonary disease) Assessment Test, CI confidence interval, FF fluticasone furoate, ITT intent to treat, LS least squares, UMEC umeclidinium, VI vilanterol
Fig. 3
Fig. 3
LS mean (95% CI) TDI focal score over 52 weeks (TDI population). *p < 0.001 for FF/UMEC/VI compared with FF/VI or UMEC/VI; **p = 0.006 for FF/UMEC/VI compared with FF/VI; ***p = 0.020 for FF/UMEC/VI compared with FF/VI. CI confidence interval, FF fluticasone furoate, LS least squares, TDI Transitional Dyspnea Index, UMEC umeclidinium, VI vilanterol
Fig. 4
Fig. 4
LS mean change (95% CI) from baseline in a use of rescue medication; b percentage of rescue medication-free days over 52 weeks; c number of nighttime awakenings per week (ITT population). *p < 0.001 for FF/UMEC/VI compared with FF/VI or UMEC/VI.; **p ≤ 0.021 for FF/UMEC/VI compared with FF/VI. Note: a negative LS mean change from baseline indicates an increase in use of rescue medication. CI confidence interval, FF fluticasone furoate, ITT intent to treat, LS least squares, UMEC umeclidinium, VI vilanterol

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