Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis

MeiLan K. Han; Gerard J. Criner; Mark T. Dransfield; David M. G. Halpin; Christine E. Jones; Sally Kilbride; Peter Lange; Sally Lettis; David A. Lipson; David A. Lomas; Neil Martin; Fernando J. Martinez; Robert A. Wise; Ian P. Naya; Dave Singh

doi:10.1183/23120541.00663-2020

Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis

MeiLan K. Han^*, Gerard J. Criner, Mark T. Dransfield, David M. G. Halpin, Christine E. Jones, Sally Kilbride, Peter Lange, Sally Lettis, David A. Lipson, David A. Lomas, Neil Martin, Fernando J. Martinez, Robert A. Wise, Ian P. Naya, Dave Singh

^*Corresponding author af dette arbejde

Afdeling for Epidemiologi

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

8 Citationer (Scopus)

17 Downloads (Pure)

Abstract

Introduction: Clinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes and the effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.

Methods: IMPACT was a phase III, double-blind, 52-week, multicentre trial. Patients with symptomatic COPD and at least one moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mu g, FF/VI 100/25 mu g or UMEC/VI 62.5/25 mu g. CID at the time-point of interest was defined as a moderate/severe exacerbation, >= 100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (increase of >= 4.0 units in St George's Respiratory Questionnaire total score or increase of >= 2.0 units in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to week 52 in patients with/without a CID by week 28. A prospective analysis evaluated time to first CID with each treatment.

Results: Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52 (all p

Conclusions: Prevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.

Originalsprog	Engelsk
Artikelnummer	00663
Tidsskrift	ERJ Open Research
Vol/bind	7
Udgave nummer	1
Antal sider	12
ISSN	2312-0541
DOI	https://doi.org/10.1183/23120541.00663-2020
Status	Udgivet - 2021

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10.1183/23120541.00663-2020Licens: CC BY

Prognostic value of clinically important deterioration in COPDForlagets udgivne version, 700 KBLicens: CC BY

Citationsformater

Han, M. K., Criner, G. J., Dransfield, M. T., Halpin, D. M. G., Jones, C. E., Kilbride, S., Lange, P., Lettis, S., Lipson, D. A., Lomas, D. A., Martin, N., Martinez, F. J., Wise, R. A., Naya, I. P., & Singh, D. (2021). Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis. ERJ Open Research, 7(1), [00663]. https://doi.org/10.1183/23120541.00663-2020

Prognostic value of clinically important deterioration in COPD : IMPACT trial analysis. / Han, MeiLan K.; Criner, Gerard J.; Dransfield, Mark T.; Halpin, David M. G.; Jones, Christine E.; Kilbride, Sally; Lange, Peter; Lettis, Sally; Lipson, David A.; Lomas, David A.; Martin, Neil; Martinez, Fernando J.; Wise, Robert A.; Naya, Ian P.; Singh, Dave.

I: ERJ Open Research, Bind 7, Nr. 1, 00663, 2021.

Publikation: Bidrag til tidsskrift › Tidsskriftartikel › Forskning › peer review

Han, MeiLan K. ; Criner, Gerard J. ; Dransfield, Mark T. ; Halpin, David M. G. ; Jones, Christine E. ; Kilbride, Sally ; Lange, Peter ; Lettis, Sally ; Lipson, David A. ; Lomas, David A. ; Martin, Neil ; Martinez, Fernando J. ; Wise, Robert A. ; Naya, Ian P. ; Singh, Dave. / Prognostic value of clinically important deterioration in COPD : IMPACT trial analysis. I: ERJ Open Research. 2021 ; Bind 7, Nr. 1.

@article{774d52b9c03d42eda93598250c7e8dec,

title = "Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis",

abstract = "Introduction: Clinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes and the effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.Methods: IMPACT was a phase III, double-blind, 52-week, multicentre trial. Patients with symptomatic COPD and at least one moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mu g, FF/VI 100/25 mu g or UMEC/VI 62.5/25 mu g. CID at the time-point of interest was defined as a moderate/severe exacerbation, >= 100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (increase of >= 4.0 units in St George's Respiratory Questionnaire total score or increase of >= 2.0 units in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to week 52 in patients with/without a CID by week 28. A prospective analysis evaluated time to first CID with each treatment.Results: Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52 (all pConclusions: Prevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.",

author = "Han, {MeiLan K.} and Criner, {Gerard J.} and Dransfield, {Mark T.} and Halpin, {David M. G.} and Jones, {Christine E.} and Sally Kilbride and Peter Lange and Sally Lettis and Lipson, {David A.} and Lomas, {David A.} and Neil Martin and Martinez, {Fernando J.} and Wise, {Robert A.} and Naya, {Ian P.} and Dave Singh",

year = "2021",

doi = "10.1183/23120541.00663-2020",

language = "English",

volume = "7",

journal = "ERJ Open Research",

issn = "2312-0541",

publisher = "ERS publications",

number = "1",

}

TY - JOUR

T1 - Prognostic value of clinically important deterioration in COPD

T2 - IMPACT trial analysis

AU - Han, MeiLan K.

AU - Criner, Gerard J.

AU - Dransfield, Mark T.

AU - Halpin, David M. G.

AU - Jones, Christine E.

AU - Kilbride, Sally

AU - Lange, Peter

AU - Lettis, Sally

AU - Lipson, David A.

AU - Lomas, David A.

AU - Martin, Neil

AU - Martinez, Fernando J.

AU - Wise, Robert A.

AU - Naya, Ian P.

AU - Singh, Dave

PY - 2021

Y1 - 2021

N2 - Introduction: Clinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes and the effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.Methods: IMPACT was a phase III, double-blind, 52-week, multicentre trial. Patients with symptomatic COPD and at least one moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mu g, FF/VI 100/25 mu g or UMEC/VI 62.5/25 mu g. CID at the time-point of interest was defined as a moderate/severe exacerbation, >= 100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (increase of >= 4.0 units in St George's Respiratory Questionnaire total score or increase of >= 2.0 units in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to week 52 in patients with/without a CID by week 28. A prospective analysis evaluated time to first CID with each treatment.Results: Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52 (all pConclusions: Prevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.

AB - Introduction: Clinically important deterioration (CID) is a multicomponent measure for assessing disease worsening in chronic obstructive pulmonary disease (COPD). This analysis investigated the prognostic value of a CID event on future clinical outcomes and the effect of single-inhaler triple versus dual therapy on reducing CID risk in patients in the IMPACT trial.Methods: IMPACT was a phase III, double-blind, 52-week, multicentre trial. Patients with symptomatic COPD and at least one moderate/severe exacerbation in the prior year were randomised 2:2:1 to fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 mu g, FF/VI 100/25 mu g or UMEC/VI 62.5/25 mu g. CID at the time-point of interest was defined as a moderate/severe exacerbation, >= 100 mL decrease in trough forced expiratory volume in 1 s or deterioration in health status (increase of >= 4.0 units in St George's Respiratory Questionnaire total score or increase of >= 2.0 units in COPD Assessment Test score) from baseline. A treatment-independent post hoc prognostic analysis compared clinical outcomes up to week 52 in patients with/without a CID by week 28. A prospective analysis evaluated time to first CID with each treatment.Results: Patients with a CID by week 28 had significantly increased exacerbation rates after week 28, smaller improvements in lung function and health status at week 52 (all pConclusions: Prevention of short-term disease worsening was associated with better long-term clinical outcomes. FF/UMEC/VI reduced CID risk versus dual therapies; this effect may improve long-term prognosis in this population.

U2 - 10.1183/23120541.00663-2020

DO - 10.1183/23120541.00663-2020

M3 - Journal article

C2 - 33718490

VL - 7

JO - ERJ Open Research

JF - ERJ Open Research

SN - 2312-0541

IS - 1

M1 - 00663

ER -