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

Research output: Contribution to journalArticlepeer-review

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 µg, FF/VI 100/25 µg or UMEC/VI 62.5/25 µg. 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<0.001), and increased risk of all-cause mortality after week 28 versus patients who were CID-free. FF/UMEC/VI significantly reduced CID risk versus dual therapies (all p<0.001). 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.

Original languageEnglish (US)
Article number00663-2020
JournalERJ Open Research
Volume7
Issue number1
DOIs
StatePublished - 2021

ASJC Scopus subject areas

  • Pulmonary and Respiratory Medicine

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