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 |
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Artikelnummer | 00663 |
Tidsskrift | ERJ Open Research |
Vol/bind | 7 |
Udgave nummer | 1 |
Antal sider | 12 |
ISSN | 2312-0541 |
DOI | |
Status | Udgivet - 2021 |