The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial

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

doi:10.1164/rccm.201912-2478OC

The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial

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

^*Corresponding author af dette arbejde

Afdeling for Epidemiologi

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

35 Citationer (Scopus)

15 Downloads (Pure)

Abstract

Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.

Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization.

Methods: Exacerbations and change from baseline in trough FEV1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days.

Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; P

Conclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.

Originalsprog	Engelsk
Tidsskrift	American Journal of Respiratory and Critical Care Medicine
Vol/bind	202
Udgave nummer	9
Sider (fra-til)	1237-1243
Antal sider	7
ISSN	1073-449X
DOI	https://doi.org/10.1164/rccm.201912-2478OC
Status	Udgivet - 2020

Adgang til dokumentet

10.1164/rccm.201912-2478OCLicens: CC BY

The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical TrialForlagets udgivne version, 807 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., Wise, R. A., Singh, D., & Martinez, F. J. (2020). The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial. American Journal of Respiratory and Critical Care Medicine, 202(9), 1237-1243. https://doi.org/10.1164/rccm.201912-2478OC

The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial. / Han, MeiLan K.; Criner, Gerard J.; Dransfield, Mark T.; Halpin, David M. G.; Jones, C. Elaine; Kilbride, Sally; Lange, Peter; Lettis, Sally; Lipson, David A.; Lomas, David A.; Martin, Neil; Wise, Robert A.; Singh, Dave; Martinez, Fernando J.

I: American Journal of Respiratory and Critical Care Medicine, Bind 202, Nr. 9, 2020, s. 1237-1243.

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

Han, MK, Criner, GJ, Dransfield, MT, Halpin, DMG, Jones, CE, Kilbride, S, Lange, P, Lettis, S, Lipson, DA, Lomas, DA, Martin, N, Wise, RA, Singh, D & Martinez, FJ 2020, 'The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial', American Journal of Respiratory and Critical Care Medicine, bind 202, nr. 9, s. 1237-1243. https://doi.org/10.1164/rccm.201912-2478OC

Han MK, Criner GJ, Dransfield MT, Halpin DMG, Jones CE, Kilbride S et al. The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial. American Journal of Respiratory and Critical Care Medicine. 2020;202(9):1237-1243. https://doi.org/10.1164/rccm.201912-2478OC

Han, MeiLan K. ; Criner, Gerard J. ; Dransfield, Mark T. ; Halpin, David M. G. ; Jones, C. Elaine ; Kilbride, Sally ; Lange, Peter ; Lettis, Sally ; Lipson, David A. ; Lomas, David A. ; Martin, Neil ; Wise, Robert A. ; Singh, Dave ; Martinez, Fernando J. / The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial. I: American Journal of Respiratory and Critical Care Medicine. 2020 ; Bind 202, Nr. 9. s. 1237-1243.

@article{bcd4542631764f9c81dbdf8ce321b0ba,

title = "The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial",

abstract = "Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization.Methods: Exacerbations and change from baseline in trough FEV1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days.Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; PConclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.",

keywords = "chronic obstructive pulmonary disease, triple therapy, step down",

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

year = "2020",

doi = "10.1164/rccm.201912-2478OC",

language = "English",

volume = "202",

pages = "1237--1243",

journal = "American Journal of Respiratory and Critical Care Medicine",

issn = "1073-449X",

publisher = "American Thoracic Society",

number = "9",

}

TY - JOUR

T1 - The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial

AU - Han, MeiLan K.

AU - Criner, Gerard J.

AU - Dransfield, Mark T.

AU - Halpin, David M. G.

AU - Jones, C. Elaine

AU - Kilbride, Sally

AU - Lange, Peter

AU - Lettis, Sally

AU - Lipson, David A.

AU - Lomas, David A.

AU - Martin, Neil

AU - Wise, Robert A.

AU - Singh, Dave

AU - Martinez, Fernando J.

PY - 2020

Y1 - 2020

N2 - Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization.Methods: Exacerbations and change from baseline in trough FEV1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days.Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; PConclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.

AB - Rationale: In the IMPACT (Informing the Pathway of Chronic Obstructive Pulmonary Disease Treatment) trial, fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) significantly reduced exacerbations compared with FF/VI or UMEC/VI in patients with symptomatic chronic obstructive pulmonary disease and a history of exacerbations.Objectives: To understand whether inhaled corticosteroid (ICS) withdrawal affected IMPACT results, given direct transition from prior maintenance medication to study medication at randomization.Methods: Exacerbations and change from baseline in trough FEV1 and St. George's Respiratory Questionnaire results were analyzed by prior ICS use. Exacerbations were also analyzed while excluding data from the first 30 days.Measurements and Main Results: FF/UMEC/VI significantly reduced the annual moderate/severe exacerbation rate compared with UMEC/VI in prior ICS users (29% reduction; PConclusions: These data support the important treatment effects of FF/UMEC/VI combination therapy on exacerbation reduction, lung function, and quality of life that do not appear to be related to abrupt ICS withdrawal.

KW - chronic obstructive pulmonary disease

KW - triple therapy

KW - step down

U2 - 10.1164/rccm.201912-2478OC

DO - 10.1164/rccm.201912-2478OC

M3 - Journal article

C2 - 32584168

VL - 202

SP - 1237

EP - 1243

JO - American Journal of Respiratory and Critical Care Medicine

JF - American Journal of Respiratory and Critical Care Medicine

SN - 1073-449X

IS - 9

ER -