Prognostic value of clinically important deterioration in COPD: IMPACT trial analysis
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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 › fagfællebedømt
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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 -
ID: 261565792