The Effect of Inhaled Corticosteroid Withdrawal and Baseline Inhaled Treatment on Exacerbations in the IMPACT Study A Randomized, Double-Blind, Multicenter Clinical Trial
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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 › fagfællebedømt
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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 -
ID: 252036641