Preventing clinically important deterioration with single-inhaler triple therapy in COPD

Autor: Ian Naya, Chris Compton, Afisi S. Ismaila, Ruby Birk, Noushin Brealey, Maggie Tabberer, Chang-Qing Zhu, David A. Lipson, Gerard Criner
Jazyk: angličtina
Rok vydání: 2018
Předmět:
Zdroj: ERJ Open Research, Vol 4, Iss 4 (2018)
Druh dokumentu: article
ISSN: 2312-0541
23120541
DOI: 10.1183/23120541.00047-2018
Popis: Clinically important deterioration (CID) is a novel composite end-point (lung function, health status, exacerbations) for assessing disease stability in patients with chronic obstructive pulmonary disease (COPD). We prospectively analysed CID in the FULFIL study. FULFIL (ClinicalTrials.gov NCT02345161; randomised, double-blind, double-dummy, multicentre study) compared 24 weeks of once daily, single-inhaler fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) 100/62.5/25 µg with twice daily budesonide/formoterol (BUD/FOR) 400/12 μg in patients aged ≥40 years with symptomatic advanced COPD (Global Initiative for Chronic Obstructive Lung Disease group D). A subset of patients received study treatment for up to 52 weeks. Time to first CID event was assessed over 24 and 52 weeks using two approaches for the health status component: St George's Respiratory Questionnaire and COPD assessment test. FF/UMEC/VI significantly reduced the risk of a first CID event by 47–52% versus BUD/FOR in the 24- and 52-week populations using both CID definitions (p
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